[Federal Register: June 26, 2003 (Volume 68, Number 123)] [Notices] [Page 38071-38083] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr26jn03-101] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 03N-0161] Medical Devices; Reprocessed Single-Use Devices; Termination of Exemptions From Premarket Notification; Requirement for Submission of Validation Data AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is adding nonelectric biopsy forceps (classified in 21 CFR 876.1075, Gastroenterology-urology biopsy instrument) to the list of critical reprocessed single-use devices (SUDs) whose exemption from premarket notification requirements is being terminated and for which validation data, as specified under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), is necessary in a premarket notification (510(k)). FDA is requiring submission of these data to ensure that reprocessed single-use nonelectric biopsy forceps are substantially equivalent to predicate devices, in accordance with MDUFMA. DATES: These actions are effective June 26, 2003. Manufacturers of reprocessed [[Page 38072]] single-use biopsy forceps must submit 510(k)s for these devices by September 27, 2004, or their devices may no longer be marketed. ADDRESSES: Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. Comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Barbara A. Zimmerman, Center for Devices and Radiological Health (HFZ-410), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850. SUPPLEMENTARY INFORMATION: I. Background On October 26, 2002, MDUFMA (Public Law 107-250) amended the Federal Food, Drug, and Cosmetic Act (the act) by adding section 510(o) (21 U.S.C. 360(o)), which provided new regulatory requirements for reprocessed SUDs. According to this new provision, in order to ensure that reprocessed SUDs are substantially equivalent to predicate devices, 510(k)s for certain reprocessed SUDs identified by FDA must include validation data. These required validation data include cleaning and sterilization data, and functional performance data demonstrating that each SUD will remain substantially equivalent to its predicate device after the maximum number of times the device is reprocessed as intended by the person submitting the premarket notification. Before enactment of the new law, a manufacturer of a reprocessed SUD was required to obtain premarket approval or premarket clearance for the device, unless the device was exempt from premarket submission requirements. Under MDUFMA, some previously exempt reprocessed SUDs will no longer be exempt from premarket notification requirements. Manufacturers of these identified devices will need to submit 510(k)s that include validation data to be specified by FDA. Reprocessors of certain SUDs that currently have cleared 510(k)s also will need to submit the validation data specified by the agency. A. Definitions Under section 302(d) of MDUFMA, a reprocessed SUD is defined as an ``* * * original device that has previously been used on a patient and has been subjected to additional processing and manufacturing for the purpose of an additional single use on a patient. The subsequent processing and manufacture of a reprocessed single-use device shall result in a device that is reprocessed within the meaning of this definition.'' B. Reprocessed SUDs Exempt From Premarket Notification Reprocessed SUDs are divided into three groups: (1) Critical, (2) semicritical, and (3) noncritical. The first two categories reflect definitions set forth in MDUFMA, and all three reflect a classification scheme recognized by the industry.\1\ These categories of devices are defined as follows: --------------------------------------------------------------------------- \1\ These are known in the industry as the Spaulding definitions, and are described in Spaulding, E. H., ``The Role of Chemical Disinfection in the Prevention of Nonsocomial Infections,'' P. S. Brachman and T. C. Eickof (ed), Proceedings of International Conference on Nonsocomial Infections, 1970, American Hospital Association, Chicago, IL 1971:254-274. --------------------------------------------------------------------------- 1. A critical reprocessed SUD is intended to contact normally sterile tissue or body spaces during use. 2. A semicritical reprocessed SUD is intended to contact intact mucous membranes and not penetrate normally sterile areas of the body. 3. A noncritical reprocessed SUD is intended to make topical contact and not penetrate intact skin. C. Requirements for Critical Reprocessed SUDs MDUFMA requires FDA to review the critical reprocessed SUDs that are currently exempt from premarket notification requirements and determine which of these devices require premarket notification to ensure their substantial equivalence to predicate devices. By April 26, 2003, FDA was required to identify in a Federal Register notice those critical reprocessed SUDs whose exemption from premarket notification requirements will be terminated and for which FDA has determined that validation data, as specified under MDUFMA, is necessary in a 510(k). According to the new law, manufacturers of the devices whose exemption from premarket notification requirements is terminated must submit 510(k)s that include validation data regarding cleaning, sterilization, and functional performance, in addition to all the other required elements of a 510(k) identified in 21 CFR 807.87, within 15 months of publication of the list or no longer market their devices. II. FDA's Implementation of New Section 510(o) of the Act In the Federal Register of April 30, 2003 (68 FR 23139), FDA described the methodology and criteria it used to determine which previously exempt critical reprocessed SUDs are now subject to 510(k) submission requirements, including the submission of validation data. First, FDA described how it identified the types of SUDs being reprocessed and how the Spaulding definitions (see footnote 1) were used to categorize these devices as critical, semicritical, or noncritical. (This list, which was Attachment 1 to that Federal Register notice, is being reprinted as Attachment 1 to this notice.) Next, the agency described its use of the Risk Prioritization Scheme (RPS)\2\ that it used to evaluate the risk (high, moderate, or low) associated with an SUD based on: (1) Risk of infection and (2) risk of inadequate performance following reprocessing. FDA identified its final risk criterion as those reprocessed SUDs intended to come in contact with tissue at high risk of being infected with the causative agents of Creutzfeldt-Jakob Disease (CJD). (These are generally devices intended for use in neurosurgery and ophthalmology.) --------------------------------------------------------------------------- \2\ This scheme is described in the agency's February 2000 draft guidance document entitled ``Reprocessing and Reuse of Single-Use Devices: Review Prioritization Scheme.'' The document is available on the Internet at http://www.fda.gov/cdrh/reuse/1156.pdf. --------------------------------------------------------------------------- Using this methodology and criteria, the devices included in List I (``Critical Reprocessed Single-Use Devices Previously Exempt From Premarket Notification Requirements That Will Now Require 510(k)s With Validation Data'') of the April 30, 2003, Federal Register notice are those critical reprocessed SUDs that were either high risk according to the RPS or intended to come in contact with tissue at high risk of being infected with the causative agents of CJD. III. Revisions to Attachment I, List I, and List II A. Revisions to Attachment I (List of SUDs Known To Be Reprocessed or Considered for Reprocessing) FDA has re-evaluated the list of reprocessed SUDs with regard to the critical and semicritical device designations. In doing so, the agency has determined that all gastroenterology-urology biopsy instruments should be considered critical devices rather than semicritical devices because these devices are intended to break the mucous membrane and come in contact with sterile tissue when taking a biopsy. This includes biopsy forceps covers, biopsy instruments, biopsy needle sets, biopsy punches, mechanical biopsy instruments, and nonelectric biopsy [[Page 38073]] forceps (devices 42-47 in Attachment I). In addition, it was determined that rigid and nonrigid bronchoscope biopsy forceps and biliary sphincterotomes (devices 40, 41, and 55 in Attachment I) should also be considered critical devices rather than semicritical devices for the same reason as stated previously. These changes are reflected in a revised version of Attachment I included in this Federal Register notice. B. Revisions to List I (Critical Reprocessed Single-Use Devices Previously Exempt From Premarket Notification Requirements That Will Now Require 510(k)s With Validation Data) FDA recategorized nine device types from semicritical to critical. One of these nine device types, nonelectric gastroenterology-urology biopsy forceps, was also considered high risk under the RPS. Therefore, nonelectric gastroenterology-urology biopsy forceps have been added to List I. Under MDUFMA, manufacturers of these biopsy forceps will be required to submit 510(k)s with validation data by (see DATES), which is 15 months following the publication of this revised list. In addition, FDA is taking this opportunity to clarify the date by which manufacturers of the other devices in List I are required to submit 510(k)s with validation data. The correct date is July 30, 2004, which is 15 months following the initial publication of the list (the April 30, 2003, Federal Register notice inadvertently identified two dates). C. Revisions to List II (Reprocessed Single-Use Devices Subject to Premarket Notification Requirements That Will Now Require the Submission of Validation Data) The only change to List II is to clarify the date by which 510(k) submissions are required by MDUFMA to be supplemented with validation data. The correct date is January 30, 2004, which is 9 months following the initial publication of the list (as noted previously, the April 30, 2003, Federal Register notice inadvertently identified two dates). List I.--Critical Reprocessed Single-Use Devices Previously Exempt From Premarket Notification Requirements That Will Now Require 510(k)s With Validation Data (to be submitted by July 30, 2004, unless otherwise noted). ------------------------------------------------------------------------ Product code Product code Product code 21 CFR Classification for non- for name for section name reprocessed reprocessed reprocessed device device device ------------------------------------------------------------------------ 872.3240 Dental bur Diamond NME Dental diamond coated coated bur ------------------------------------------------------------------------ 872.4535 Dental diamond DZP NLD Dental diamond instrument instrument ------------------------------------------------------------------------ 872.4730 Dental injection DZM NMW Dental needle needle ------------------------------------------------------------------------ 874.4140 Ear, nose, and Microdebrider NLY ENT high speed throat (ENT) microdebrider bur ------------------------------------------------------------------------ 874.4140 Ear, nose, and Diamond NLZ ENT diamond throat bur coated coated bur ------------------------------------------------------------------------ 874.4420 Ear, nose, KAB, KBG, KCI NLB Laryngeal, throat manual sinus, surgical tracheal instrument trocar ------------------------------------------------------------------------ 876.1075\ Gastroenterology- FCL NON Nonelectric 1\ urology biopsy biopsy instrument forceps ------------------------------------------------------------------------ 878.4200 Introduction/ GCB NMT Catheter drainage needle catheter and accessories ------------------------------------------------------------------------ 878.4800 Manual surgical MJG NNA Percutaneous instrument biopsy device ------------------------------------------------------------------------ 878.4800 Manual surgical FHR NMU Gastro-urology instrument needle ------------------------------------------------------------------------ 878.4800 Manual surgical DWO NLK Cardiovascular instrument for biopsy needle general use ------------------------------------------------------------------------ 878.4800 Manual surgical GAA NNC Aspiration and instrument for injection general use needle ------------------------------------------------------------------------ 882.4190 Forming/cutting HBS NMN Forming/ clip instrument cutting clip instrument ------------------------------------------------------------------------ 884.1730 Laparoscopic HIF NMI Laparoscopic insufflator insufflator and accessories ------------------------------------------------------------------------ 884.4530 OB/GYN HFB NMG Gynecological specialized biopsy manual forceps instrument ------------------------------------------------------------------------ 886.4350 Manual HNN NLA Ophthalmic ophthalmic knife surgical instrument ------------------------------------------------------------------------ \1\ 510(k)s with validation data to be submitted by September 27, 2004. [[Page 38074]] List II.--Reprocessed Single-Use Devices Subject to Premarket Notification Requirements That Will Now Require the Submission of Validation Data\1\ (Manufacturers who already have 510(k) clearance for these devices must submit validation data by January 30, 2004. Any new 510(k) submitted after publication of the April 30 list will require validation data.) ------------------------------------------------------------------------ Product code Product code Product code 21 CFR Classification for non- for name for section name reprocessed reprocessed reprocessed device device device ------------------------------------------------------------------------ Unclassif Oocyte MHK NMO Oocyte ied aspiration aspiration needles needles ------------------------------------------------------------------------ Unclassif Percutaneous LIT NMM Transluminal ied transluminal peripheral angioplasty angioplasty catheter catheter ------------------------------------------------------------------------ Unclassif Ultrasonic LFL NLQ Ultrasonic ied surgical scalpel instrument ------------------------------------------------------------------------ 868.5150 Anesthesia BSP NNH Anesthetic conduction conduction needle needle (with or without introducer) ------------------------------------------------------------------------ 868.5150 Anesthesia MIA NMR Short term conduction spinal needle needle ------------------------------------------------------------------------ 868.5730 Tracheal tube BTR NMA Tracheal tube (with or without connector) ------------------------------------------------------------------------ 868.5905 Noncontinuous BZD NMC Noncontinuous ventilator ventilator (IPPB) (respirator) mask ------------------------------------------------------------------------ 870.1200 Diagnostic DQO NLI Angiography intravascular catheter catheter ------------------------------------------------------------------------ 870.1220 Electrode DRF NLH Electrode recording recording catheter catheter ------------------------------------------------------------------------ 870.1220 Electrode MTD NLG Intracardiac recording mapping catheter catheter ------------------------------------------------------------------------ 870.1230 Fiberoptic DQE NMB Fiberoptic oximeter oximeter catheter catheter ------------------------------------------------------------------------ 870.1280 Steerable DRA NKS Steerable catheter catheter ------------------------------------------------------------------------ 870.1290 Steerable DXX NKR Steerable catheter catheter control system control system ------------------------------------------------------------------------ 870.1330 Catheter guide DQX NKQ Catheter guide wire wire ------------------------------------------------------------------------ 870.1390 Trocar DRC NMK Cardiovascular trocar ------------------------------------------------------------------------ 870.1650 Angiographic DXT NKT Angiographic injector and injector and syringe syringe ------------------------------------------------------------------------ 870.1670 Syringe actuator DQF NKW Injector for for injector actuator syringe ------------------------------------------------------------------------ 870.2700 Oximeter MUD NMD Tissue saturation oximeter ------------------------------------------------------------------------ 870.2700 Oximeter DQA NLF Oximeter ------------------------------------------------------------------------ 870.3535 Intra-aortic DSP NKO Intra-aortic balloon and balloon and control system control system ------------------------------------------------------------------------ 870.4450 Vascular clamp DXC NMF Vascular clamp ------------------------------------------------------------------------ 870.4885 External vein DWQ NLJ External vein stripper stripper ------------------------------------------------------------------------ 872.5470 Orthodontic DYW NLC Orthodontic plastic bracket plastic bracket ------------------------------------------------------------------------ 874.4680 Bronchoscope BWH NLE Bronchoscope (flexible or (nonrigid) rigid) and biopsy accessories forceps ------------------------------------------------------------------------ 876.1075 Gastro-urology FCG NMX G-U biopsy biopsy needle and instrument needle set ------------------------------------------------------------------------ 876.1075 Gastroenterology- KNW NLS Biopsy urology biopsy instrument instrument ------------------------------------------------------------------------ 876.1500 Endoscope and FBK, FHP NMY Endoscopic accessories needle ------------------------------------------------------------------------ 876.1500 Endoscope and MPA NKZ Endoilluminato accessories r ------------------------------------------------------------------------ 876.1500 Endoscope and GCJ NLM General and accessories plastic surgery laparoscope ------------------------------------------------------------------------ 876.1500 Endoscope and FHO NLX Spring-loaded accessories Pneumoperiton eum Needle ------------------------------------------------------------------------ [[Page 38075]] 876.4300 Endoscopic FAS NLW Active electrosurgical urological unit and electrosurgic accessories al electrode ------------------------------------------------------------------------ 876.4300 Endoscopic FEH NLV Flexible electrosurgical suction unit and coagulator accessories electrode ------------------------------------------------------------------------ 876.4300 Endoscopic KGE NLU Electric electrosurgical biopsy unit and forceps accessories ------------------------------------------------------------------------ 876.4300 Endoscopic FDI NLT Flexible snare electrosurgical unit and accessories ------------------------------------------------------------------------ 876.4300 Endoscopic KNS NLR Endoscopic electrosurgical (with or unit and without accessories accessories) Electrosurgic al unit ------------------------------------------------------------------------ 876.5010 Biliary catheter FGE NML Biliary and accessories catheter ------------------------------------------------------------------------ 876.5540 Blood access LBW NNF Single needle device and dialysis set accessories (co-axial flow) ------------------------------------------------------------------------ 876.5540 Blood access FIE NNE Fistula needle device and accessories ------------------------------------------------------------------------ 876.5820 Hemodialysis FIF NNG Single needle systems and dialysis set accessories with uni- directional pump ------------------------------------------------------------------------ 878.4300 Implantable clip FZP NMJ Implantable clip ------------------------------------------------------------------------ 878.4750 Implantable GDW NLL Implantable staple staple ------------------------------------------------------------------------ 880.5570 Hypodermic FMI NKK Hypodermic single lumen single lumen needle needle ------------------------------------------------------------------------ 880.5860 Piston syringe FMF NKN Piston syringe ------------------------------------------------------------------------ 882.4300 Manual cranial HBG NLO (Manual) drills, burrs, drills, trephines, and burrs, accessories trephines, and accessories ------------------------------------------------------------------------ 882.4305 Powered compound HBF NLP (Powered, cranial drills, compound) burrs, drills, trephines, and burrs, accessories trephines, and accessories ------------------------------------------------------------------------ 882.4310 Powered simple HBE NLN (Simple, cranial drills, powered) burrs, drills, trephines, and burrs, accessories trephines, and accessories ------------------------------------------------------------------------ 884.1720 Gynecologic HET NMH Gynecologic laparoscope and laparoscope accessories (and accessories) ------------------------------------------------------------------------ 884.6100 Assisted MQE NNB Assisted reproduction reproduction needles needles ------------------------------------------------------------------------ 886.4370 Keratome HMY, HNO NKY Keratome blade ------------------------------------------------------------------------ 886.4670 Phacofragmentati HQC NKX Phacoemulsific on system ation needle ------------------------------------------------------------------------ 892.5730 Radionuclide IWF NMP Isotope needle brachytherapy source ------------------------------------------------------------------------ \1\ Hemodialyzers have been excluded from this list because the reuse of hemodialyzers is addressed in FDA's ``Guidance for Hemodialyzer Reuse Labeling'' (final draft issued on October 6, 1995). IV. Comments You may submit written or electronic comments on this notice to the Division of Dockets Management (see ADDRESSES). You may submit a single copy of an electronic comment to http://www.fda.gov/dockets/ecomments. You should submit two paper copies of any mailed comments but individuals may submit one paper copy. You should identify your comment with the docket number found in brackets in the heading of this document. You may see any comments FDA receives in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. [[Page 38076]] Attachment 1--List of SUDs Known To Be Reprocessed or Considered for Reprocessing June 26, 2003 ---------------------------------------------------------------------------------------------------------------- Critical/semi- Medical Device type 21 CFR Class Product Risk* critical/ Premarket specialty section code noncritical exempt ---------------------------------------------------------------------------------------------------------------- 1 Cardio Cardiopulmonary unclassifi ........ MAB 1 C N\1\ Bypass Marker ed ---------------------------------------------------------------------------------------------------------------- 2 Cardio Percutaneous & post- III LOX 3 C N Operative amendment Transluminal Coronary Angioplasty Catheter (PTCA) ---------------------------------------------------------------------------------------------------------------- 3 Cardio Percutaneous post- III LPB 3 C N Ablation amendment Electrode ---------------------------------------------------------------------------------------------------------------- 4 Cardio Peripheral unclassifi ........ LIT 3 C N Transluminal ed Angioplasty (PTA) Catheter ---------------------------------------------------------------------------------------------------------------- 5 Cardio Blood-Pressure 870.1120 II DXQ 1 N N Cuff ---------------------------------------------------------------------------------------------------------------- 6 Cardio Angiography 870.1200 II DQO 3 C N Catheter ---------------------------------------------------------------------------------------------------------------- 7 Cardio Electrode 870.1220 II DRF 3 C N Recording Catheter ---------------------------------------------------------------------------------------------------------------- 8 Cardio High-Density 870.1220 II MTD 3 C N Array Catheter ---------------------------------------------------------------------------------------------------------------- 9 Cardio Fiberoptic 870.1230 II DQE 3 C N Oximeter Catheter ---------------------------------------------------------------------------------------------------------------- 10 Cardio Steerable 870.1280 II DRA 3 C N Catheter ---------------------------------------------------------------------------------------------------------------- 11 Cardio Steerable 870.1290 II DXX 3 C N Catheter Control System ---------------------------------------------------------------------------------------------------------------- 12 Cardio Guide Wire 870.1330 II DQX 3 C N ---------------------------------------------------------------------------------------------------------------- 13 Cardio Angiographic 870.1390 II DRC 3 C N Needle ---------------------------------------------------------------------------------------------------------------- 14 Cardio Trocar 870.1390 II DRC 3 C N ---------------------------------------------------------------------------------------------------------------- 15 Cardio Syringes 870.1650 II DXT 3 C N ---------------------------------------------------------------------------------------------------------------- 16 Cardio Injector Type 870.1670 II DQF 3 C N Syringe Actuator ---------------------------------------------------------------------------------------------------------------- 17 Cardio Oximeter 870.2700 II DQA 3 N N ---------------------------------------------------------------------------------------------------------------- 18 Cardio Tissue 870.2700 II MUD 3 C N Saturation Oximeter ---------------------------------------------------------------------------------------------------------------- 19 Cardio Intra-Aortic 870.3535 III DSP 3 C N Balloon System ---------------------------------------------------------------------------------------------------------------- 20 Cardio Vascular Clamp 870.4450 II DXC 3 C N ---------------------------------------------------------------------------------------------------------------- 21 Cardio Device, 870.4500 I MWS 2 C Y\2\ Stabilizer, Heart ---------------------------------------------------------------------------------------------------------------- 22 Cardio External Vein 870.4885 II DWQ 3 C N Stripper ---------------------------------------------------------------------------------------------------------------- 23 Cardio Compressible 870.5800 II JOW 1 N N Limb Sleeve ---------------------------------------------------------------------------------------------------------------- 24 Dental Bur 872.3240 I EJL 1 C Y ---------------------------------------------------------------------------------------------------------------- 25 Dental Diamond Coated 872.3240 I EJL 3 C Y Bur ---------------------------------------------------------------------------------------------------------------- 26 Dental Diamond 872.4535 I DZP 3 C Y Instrument ---------------------------------------------------------------------------------------------------------------- 27 Dental AC-Powered Bone 872.4120 II DZH 2 C N Saw ---------------------------------------------------------------------------------------------------------------- 28 Dental Manual Bone 872.4120 II DZJ 2 C N Drill and Wire Driver ---------------------------------------------------------------------------------------------------------------- 29 Dental Powered Bone 872.4120 II DZI 2 C N Drill ---------------------------------------------------------------------------------------------------------------- 30 Dental Intraoral Drill 872.4130 I DZA 1 C Y ---------------------------------------------------------------------------------------------------------------- 31 Dental Injection needle 872.4730 I DZM 3 C Y ---------------------------------------------------------------------------------------------------------------- 32 Dental Metal 872.5410 I EJF 3 S Y Orthodontic Bracket ---------------------------------------------------------------------------------------------------------------- [[Page 38077]] 33 Dental Plastic 872.5470 II DYW 3 S N Orthodontic Bracket ---------------------------------------------------------------------------------------------------------------- 34 ENT Bur 874.4140 I EQJ 1 C Y ---------------------------------------------------------------------------------------------------------------- 35 ENT Diamond Coated 874.4140 I EQJ 3 C Y Bur ---------------------------------------------------------------------------------------------------------------- 36 ENT Microdebrider 874.4140 I EQJ 3 C Y ---------------------------------------------------------------------------------------------------------------- 37 ENT Microsurgical 874.4490 II LMS 1 S N Argon Fiber Optic Laser Cable, for Uses Other Than Otology, Including Laryngology and General Use in Otolaryngology ---------------------------------------------------------------------------------------------------------------- 38 ENT Microsurgical 874.4490 II LXR 1 S N Argon Fiber Optic Laser Cable for Use in Otology ---------------------------------------------------------------------------------------------------------------- 39 ENT Microsurgical 874.4500 II EWG 1 S N Carbon-Dioxide Fiber Optic Laser Cable ---------------------------------------------------------------------------------------------------------------- 40 ENT Bronchoscope 874.4680 II BWH 3 C N [dagg Biopsy Forceps er] (Nonrigid) ---------------------------------------------------------------------------------------------------------------- 41 ENT Bronchoscope 874.4680 II JEK 1 C N [dagg Biopsy Forceps er] (Rigid) ---------------------------------------------------------------------------------------------------------------- 42 Gastro/ Biopsy Forceps 876.1075 I FFF 1 C Y [dagg Urology Cover er] ---------------------------------------------------------------------------------------------------------------- 43 Gastro/ Biopsy 876.1075 II KNW 3 C N [dagg Urology Instrument er] ---------------------------------------------------------------------------------------------------------------- 44 Gastro/ Biopsy Needle 876.1075 II FCG 3 C N [dagg Urology Set er] ---------------------------------------------------------------------------------------------------------------- 45 Gastro/ Biopsy Punch 876.1075 II FCI 2 C N [dagg Urology er] ---------------------------------------------------------------------------------------------------------------- 46 Gastro/ Mechanical 876.1075 II FCF 2 C N [dagg Urology Biopsy er] Instrument ---------------------------------------------------------------------------------------------------------------- 47 Gastro/ Nonelectric 876.1075 I FCL 3 C Y [dagg Urology Biopsy Forceps er] ---------------------------------------------------------------------------------------------------------------- 48 Gastro/ Cytology Brush 876.1500 II FDX 2 S N Urology for Endoscope ---------------------------------------------------------------------------------------------------------------- 49 Gastro/ Endoscope 876.1500 II KOG 2 S N Urology accessories ---------------------------------------------------------------------------------------------------------------- 50 Gastro/ Extraction 876.1500 II KOG 2 S N Urology Balloons/ Baskets ---------------------------------------------------------------------------------------------------------------- 51 Gastro/ Endoscopic 876.1500 II FBK 3 C N Urology needle ---------------------------------------------------------------------------------------------------------------- 52 Gastro/ Simple 876.1500 II FHP 3 C N Urology Pneumoperitoneu m Needle ---------------------------------------------------------------------------------------------------------------- 53 Gastro/ Spring Loaded 876.1500 II FHO 3 C N Urology Pneumoperitoneu m Needle ---------------------------------------------------------------------------------------------------------------- 54 Gastro/ Active 876.4300 II FAS 3 S N Urology Electrosurgical Electrode ---------------------------------------------------------------------------------------------------------------- 55 Gastro/ Biliary 876.5010, II FGE 3 C N [dagg Urology Sphincterotomes 876.1500 er] ---------------------------------------------------------------------------------------------------------------- 56 Gastro/ Electric Biopsy 876.4300 II KGE 3 C N Urology Forceps ---------------------------------------------------------------------------------------------------------------- 57 Gastro/ Electrosurgical 876.4300 II KNS 3 S N Urology Endoscopic Unit (With or Without Accessories) ---------------------------------------------------------------------------------------------------------------- 58 Gastro/ Flexible Snare 876.4300 II FDI 3 S N Urology ---------------------------------------------------------------------------------------------------------------- 59 Gastro/ Flexible Suction 876.4300 II FEH 3 S N Urology Coagulator Electrode ---------------------------------------------------------------------------------------------------------------- [[Page 38078]] 60 Gastro/ Flexible Stone 876.4680 II FGO 3 S Y Urology Dislodger ---------------------------------------------------------------------------------------------------------------- 61 Gastro/ Metal Stone 876.4680 II FFL 3 S Y Urology Dislodger ---------------------------------------------------------------------------------------------------------------- 62 Gastro/ Needle Holder 876.4730 I FHQ 1 C Y Urology ---------------------------------------------------------------------------------------------------------------- 63 Gastro/ Nonelectrical 876.4730 I FGX 1 S Y Urology Snare ---------------------------------------------------------------------------------------------------------------- 64 Gastro/ Urological 876.5130 II KOD 2 S N Urology Catheter ---------------------------------------------------------------------------------------------------------------- 65 Gastro/ Single Needle 876.5540 II LBW, FIE 3 C N Urology Dialysis Set ---------------------------------------------------------------------------------------------------------------- 66 Gastro/ Hemodialysis 876.5820 II KOC 2 S N Urology Blood Circuit Accessories ---------------------------------------------------------------------------------------------------------------- 67 Gastro/ Single Needle 876.5820 II FIF 3 C N Urology Dialysis Set ---------------------------------------------------------------------------------------------------------------- 68 GE/U Hemorrhoidal 876.4400 II FHN 2 C N Ligator ---------------------------------------------------------------------------------------------------------------- 69 General Implanted, post- III LKK 3 C N Hospital Programmable amendment Infusion Pump ---------------------------------------------------------------------------------------------------------------- 70 General Needle post- III MTV 1 N N Hospital Destruction amendment Device ---------------------------------------------------------------------------------------------------------------- 71 General Nonpowered 880.5150 I IKY 2 N Y Hospital Flotation Therapy Mattress ---------------------------------------------------------------------------------------------------------------- 72 General Non-AC-Powered 880.5510 I FSA 2 N Y Hospital Patient Lift ---------------------------------------------------------------------------------------------------------------- 73 General Alternating 880.5550 II FNM 1 N Y Hospital Pressure Air Flotation Mattress ---------------------------------------------------------------------------------------------------------------- 74 General Temperature 880.5560 I FOH 2 N Y Hospital Regulated Water Mattress ---------------------------------------------------------------------------------------------------------------- 75 General Hypodermic 880.5570 II FMI 3 C N Hospital Single Lumen Needle ---------------------------------------------------------------------------------------------------------------- 76 General Piston Syringe 880.5860 II FMF 3 C N Hospital ---------------------------------------------------------------------------------------------------------------- 77 General Mattress Cover 880.6190 I FMW 2 N Y Hospital (Medical Purposes) ---------------------------------------------------------------------------------------------------------------- 78 General Disposable 880.6820 I JOK 1 N Y Hospital Medical Scissors ---------------------------------------------------------------------------------------------------------------- 79 General Irrigating 880.6960 I KYZ, KYY 1 C Y Hospital Syringe ---------------------------------------------------------------------------------------------------------------- 80 Infection Surgical Gowns 878.4040 II FYA 1 C N Control ---------------------------------------------------------------------------------------------------------------- 81 Lab Blood Lancet 878.4800 I FMK 1 C Y ---------------------------------------------------------------------------------------------------------------- 82 Neuro Clip Forming/ 882.4190 I HBS 3* C Y Cutting Instrument, ---------------------------------------------------------------------------------------------------------------- 83 Neuro Drills, Burrs, 882.4300 II HBG 3* C N Trephines, and Accessories (Manual) ---------------------------------------------------------------------------------------------------------------- 84 Neuro Drills, Burrs, 882.4305 II HBF 3* C N Trephines, and Accessories (Compound, Powered) ---------------------------------------------------------------------------------------------------------------- 85 Neuro Drills, Burrs, 882.4310 II HBE 3* C N Trephines, and Accessories (Simple, Powered) ---------------------------------------------------------------------------------------------------------------- 86 OB/GYN Oocyte Unclassifi II MHK 3 C N Aspiration ed Needle ---------------------------------------------------------------------------------------------------------------- 87 OB/GYN Laparoscope 884.1720 I HET 2 C Y Accessories ---------------------------------------------------------------------------------------------------------------- [[Page 38079]] 88 OB/GYN Laparoscope 884.1720 II HET 3 C N Accessories ---------------------------------------------------------------------------------------------------------------- 89 OB/GYN Laparoscopic 884.1720 I HET 2 C Y Dissectors ---------------------------------------------------------------------------------------------------------------- 90 OB/GYN Laparoscopic 884.1720 I HET 2 C Y Graspers ---------------------------------------------------------------------------------------------------------------- 91 OB/GYN Laparoscopic 884.1720 I HET 2 C Y Scissors ---------------------------------------------------------------------------------------------------------------- 92 OB/GYN Insufflator 884.1730 II HIF 3 C Y Accessories (Tubing, Verres Needle, Kits) ---------------------------------------------------------------------------------------------------------------- 93 OB/GYN Laparoscopic 884.1730 II HIF 2 N N Insufflator ---------------------------------------------------------------------------------------------------------------- 94 OB/GYN Endoscopic 884.4100 II HIM 2 N N Electrocautery and Accessories ---------------------------------------------------------------------------------------------------------------- 95 OB/GYN Gynecologic 884.4120 II HGI 2 N N Electrocautery (and Accessories) ---------------------------------------------------------------------------------------------------------------- 96 OB/GYN Endoscopic 884.4150 II HIN 2 N N Bipolar Coagulator- Cutter (and Accessories) ---------------------------------------------------------------------------------------------------------------- 97 OB/GYN Culdoscopic 884.4160 II HFI 2 N N Coagulator (and Accessories) ---------------------------------------------------------------------------------------------------------------- 98 OB/GYN Endoscopic 884.4160 II KNF 2 N N Unipolar Coagulator- Cutter (and Accessories) ---------------------------------------------------------------------------------------------------------------- 99 OB/GYN Hysteroscopic 884.4160 II HFH 2 N N Coagulator (and Accessories) ---------------------------------------------------------------------------------------------------------------- 100 OB/GYN Unipolar 884.4160 II HFG 2 N N Laparoscopic Coagulator (and Accessories) ---------------------------------------------------------------------------------------------------------------- 101 OB/GYN Episiotomy 884.4520 I HDK 1 C Y Scissors ---------------------------------------------------------------------------------------------------------------- 102 OB/GYN Umbilical 884.4520 I HDJ 1 C Y Scissors ---------------------------------------------------------------------------------------------------------------- 103 OB/GYN Biopsy Forceps 884.4530 I HFB 3 C Y ---------------------------------------------------------------------------------------------------------------- 104 OB/GYN Assisted 884.6100 II MQE 3 C N Reproduction Needles ---------------------------------------------------------------------------------------------------------------- 105 Ophthalmic Endoilluminator 876.1500 II MPA 3* C N ---------------------------------------------------------------------------------------------------------------- 106 Ophthalmic Surgical Drapes 878.4370 II KKX 2 C N ---------------------------------------------------------------------------------------------------------------- 107 Ophthalmic Ophthalmic Knife 886.4350 I HNN 3 C Y ---------------------------------------------------------------------------------------------------------------- 108 Ophthalmic Keratome Blade 886.4370 I not HMY, HNO 3 C N exempt ---------------------------------------------------------------------------------------------------------------- 109 Ophthalmic Phacoemulsificat 886.4670 II HQC 3 C N ion Needle ---------------------------------------------------------------------------------------------------------------- 110 Ophthalmic Phacoemulsificat 886.4670 II MUS 2 C N ion/ Phacofragmentat ion Fluidic ---------------------------------------------------------------------------------------------------------------- 111 Ophthalmic Phacofragmentati 886.4670 II HQC 1 N N on Unit ---------------------------------------------------------------------------------------------------------------- 112 Ortho Saw Blades 878.4820 I GFA, DWH, 1 C Y GEY, GET ---------------------------------------------------------------------------------------------------------------- 113 Ortho Surgical Drills 878.4820 I GEY, GET 1 C Y ---------------------------------------------------------------------------------------------------------------- 114 Ortho Arthroscope 888.1100 II HRX 2 C Y accessories ---------------------------------------------------------------------------------------------------------------- [[Page 38080]] 115 Ortho Bone Tap 888.4540 I HWX 1 C Y ---------------------------------------------------------------------------------------------------------------- 116 Ortho Burr 888.4540 I HTT 1 C Y ---------------------------------------------------------------------------------------------------------------- 117 Ortho Carpal Tunnel 888.4540 I LXH 2 C Y Blade ---------------------------------------------------------------------------------------------------------------- 118 Ortho Countersink 888.4540 I HWW 1 C Y ---------------------------------------------------------------------------------------------------------------- 119 Ortho Drill Bit 888.4540 I HTW 1 C Y ---------------------------------------------------------------------------------------------------------------- 120 Ortho Knife 888.4540 I HTS 1 C Y ---------------------------------------------------------------------------------------------------------------- 121 Ortho Manual Surgical 888.4540 I LXH 1 C Y Instrument ---------------------------------------------------------------------------------------------------------------- 122 Ortho Needle Holder 888.4540 I HXK 1 C Y ---------------------------------------------------------------------------------------------------------------- 123 Ortho Reamer 888.4540 I HTO 1 C Y ---------------------------------------------------------------------------------------------------------------- 124 Ortho Rongeur 888.4540 I HTX 1 C Y ---------------------------------------------------------------------------------------------------------------- 125 Ortho Scissors 888.4540 I HRR 1 C Y ---------------------------------------------------------------------------------------------------------------- 126 Ortho Staple Driver 888.4540 I HXJ 1 C Y ---------------------------------------------------------------------------------------------------------------- 127 Ortho Trephine 888.4540 I HWK 1 C Y ---------------------------------------------------------------------------------------------------------------- 128 Ortho Flexible Reamers/ 886.4070 I GEY, HRG 1 C Y Drills 878.4820 ---------------------------------------------------------------------------------------------------------------- 129 Ortho External 888.3040 II JEC, KTW, 2 N N Fixation Frame 888.3030 KTT ---------------------------------------------------------------------------------------------------------------- 130 Physical Non-Heating Lamp unclassifi ........ NHN 1 N N Medicine for Adjunctive ed Use Inpatient Therapy ---------------------------------------------------------------------------------------------------------------- 131 Physical Electrode Cable 890.1175 II IKD 1 N Y Medicine ---------------------------------------------------------------------------------------------------------------- 132 Physical External Limb 890.3420 I ISL 2 N Y Medicine Component, Hip Joint ---------------------------------------------------------------------------------------------------------------- 133 Physical External Limb 890.3420 I ISY 2 N Y Medicine Component, Knee Joint ---------------------------------------------------------------------------------------------------------------- 134 Physical External Limb 890.3420 I ISZ 2 N Y Medicine Component, Mechanical Wrist ---------------------------------------------------------------------------------------------------------------- 135 Physical External Limb 890.3420 I IQQ 2 N Y Medicine Component, Shoulder Joint ---------------------------------------------------------------------------------------------------------------- 136 Plastic Stapler 878.4800 I GAG, GEF, 2 C Y Surgery FHM, HBT ---------------------------------------------------------------------------------------------------------------- 137 Radiology Isotope Needle 892.5730 II IWF 3 C N ---------------------------------------------------------------------------------------------------------------- 138 Resp Endotracheal unclassifi III LNZ 3 C N Tube Changer ed ---------------------------------------------------------------------------------------------------------------- 139 Resp Anesthesia 868.5150 II BSP 3 C N conduction needle ---------------------------------------------------------------------------------------------------------------- 140 Resp Short term 868.5150 II MIA 3 C N spinal needle ---------------------------------------------------------------------------------------------------------------- 141 Resp Respiratory 868.5240 I CAI 2 S Y Therapy and Anesthesia Breathing Circuits ---------------------------------------------------------------------------------------------------------------- 142 Resp Oral and Nasal 868.5350 I BZB 1 C Y Catheters ---------------------------------------------------------------------------------------------------------------- 143 Resp Gas Masks 868.5550 I BSJ 1 S Y ---------------------------------------------------------------------------------------------------------------- 144 Resp Breathing 868.5620 I BYP 1 N Y Mouthpiece ---------------------------------------------------------------------------------------------------------------- [[Page 38081]] 145 Resp Tracheal Tube 868.5730 II BTR 3 C N ---------------------------------------------------------------------------------------------------------------- 146 Resp Airway Connector 868.5810 I BZA 2 S Y ---------------------------------------------------------------------------------------------------------------- 147 Resp CPAP Mask 868.5905 II BZD 3 S N ---------------------------------------------------------------------------------------------------------------- 148 Resp Emergency Manual 868.5915 II BTM 2 S N Resuscitator ---------------------------------------------------------------------------------------------------------------- 149 Resp Tracheobronchial 868.6810 I BSY 3 S Y Suction Catheter ---------------------------------------------------------------------------------------------------------------- 150 Surgery AC-Powered unclassifi ........ HWE 2 C N Orthopedic ed Instrument and Accessories ---------------------------------------------------------------------------------------------------------------- 151 Surgery Breast Implant unclassifi ........ MRD 1 C N Mammary Sizer ed ---------------------------------------------------------------------------------------------------------------- 152 Surgery Ultrasonic unclassifi ........ LFL 3 C N Surgical ed Instrument ---------------------------------------------------------------------------------------------------------------- 153 Surgery Trocar 874.4420 I KAB, KBG, 3 C Y KCI ---------------------------------------------------------------------------------------------------------------- 154 Surgery Endoscopic 876.1500 II GCP, GCR 2 C N Blades ---------------------------------------------------------------------------------------------------------------- 155 Surgery Endoscopic 876.1500 II GCP, GCR 1 C N Guidewires ---------------------------------------------------------------------------------------------------------------- 156 Surgery Inflatable 878.3900 I FZF 1 N Y External Extremity Splint ---------------------------------------------------------------------------------------------------------------- 157 Surgery Noninflatable 878.3910 I FYH 1 N Y External Extremity Splint ---------------------------------------------------------------------------------------------------------------- 158 Surgery Catheter Needle 878.4200 I GCB 3 C Y ---------------------------------------------------------------------------------------------------------------- 159 Surgery Implantable Clip 878.4300 II FZP 3 C N ---------------------------------------------------------------------------------------------------------------- 160 Surgery Electrosurgical 878.4400 II BWA 2 C N and Coagulation Unit With Accessories ---------------------------------------------------------------------------------------------------------------- 161 Surgery Electrosurgical 878.4400 II HAM 2 C N Apparatus ---------------------------------------------------------------------------------------------------------------- 162 Surgery Electrosurgical 878.4400 II GEI 2 C N Cutting and Coagulation Device and Accessories ---------------------------------------------------------------------------------------------------------------- 163 Surgery Electrosurgical 878.4400 II DWG 2 C N Device ---------------------------------------------------------------------------------------------------------------- 164 Surgery Electrosurgical 878.4400 II JOS 2 C N Electrode ---------------------------------------------------------------------------------------------------------------- 165 Surgery Implantable 878.4750 II GDW 3 C N Staple, Clamp, Clip for Suturing Apparatus ---------------------------------------------------------------------------------------------------------------- 166 Surgery Percutaneous 878.4800 I MJG 3 C Y Biopsy Device ---------------------------------------------------------------------------------------------------------------- 167 Surgery Gastro-Urology 878.4800 I FHR 3 C Y Needle ---------------------------------------------------------------------------------------------------------------- 168 Surgery Aspiration and 878.4800 I GAA 3 C Y Injection Needle ---------------------------------------------------------------------------------------------------------------- 169 Surgery Biopsy Brush 878.4800 I GEE 1 C Y ---------------------------------------------------------------------------------------------------------------- 170 Surgery Blood Lancet 878.4800 I FMK 1 C Y ---------------------------------------------------------------------------------------------------------------- 171 Surgery Bone Hook 878.4800 I KIK 1 C Y ---------------------------------------------------------------------------------------------------------------- 172 Surgery Cardiovascular 878.4800 I DWO 3 C Y Biopsy Needle ---------------------------------------------------------------------------------------------------------------- 173 Surgery Clamp 878.4800 I GDJ 1 C Y ---------------------------------------------------------------------------------------------------------------- 174 Surgery Clamp 878.4800 I HXD 1 C Y ---------------------------------------------------------------------------------------------------------------- [[Page 38082]] 175 Surgery Curette 878.4800 I HTF 1 C Y ---------------------------------------------------------------------------------------------------------------- 176 Surgery Disposable 878.4800 I KDC 1 C Y Surgical Instrument ---------------------------------------------------------------------------------------------------------------- 177 Surgery Disposable Vein 878.4800 I GAJ 1 C Y Stripper ---------------------------------------------------------------------------------------------------------------- 178 Surgery Dissector 878.4800 I GDI 1 C Y ---------------------------------------------------------------------------------------------------------------- 179 Surgery Forceps 878.4800 I GEN 2 C Y ---------------------------------------------------------------------------------------------------------------- 180 Surgery Forceps 878.4800 I HTD 2 C Y ---------------------------------------------------------------------------------------------------------------- 181 Surgery Gouge 878.4800 I GDH 1 C Y ---------------------------------------------------------------------------------------------------------------- 182 Surgery Hemostatic Clip 878.4800 I HBT 2 C Y Applier ---------------------------------------------------------------------------------------------------------------- 183 Surgery Hook 878.4800 I GDG 1 C Y ---------------------------------------------------------------------------------------------------------------- 184 Surgery Manual 878.4800 I MDM, MDW 1 C Y Instrument ---------------------------------------------------------------------------------------------------------------- 185 Surgery Manual Retractor 878.4800 I GZW 1 C Y ---------------------------------------------------------------------------------------------------------------- 186 Surgery Manual Saw and 878.4800 I GDR, HAC 1 C Y Accessories ---------------------------------------------------------------------------------------------------------------- 187 Surgery Manual Saw and 878.4800 I HAC 1 C Y Accessories ---------------------------------------------------------------------------------------------------------------- 188 Surgery Manual Surgical 878.4800 I FZO 1 C Y Chisel ---------------------------------------------------------------------------------------------------------------- 189 Surgery Mastoid Chisel 878.4800 I JYD 1 C Y ---------------------------------------------------------------------------------------------------------------- 190 Surgery Orthopedic 878.4800 I HTZ 1 C Y Cutting Instrument ---------------------------------------------------------------------------------------------------------------- 191 Surgery Orthopedic 878.4800 I HXR 1 C Y Spatula ---------------------------------------------------------------------------------------------------------------- 192 Surgery Osteotome 878.4800 I HWM 1 C Y ---------------------------------------------------------------------------------------------------------------- 193 Surgery Rasp 878.4800 I GAC 1 C Y ---------------------------------------------------------------------------------------------------------------- 194 Surgery Rasp 878.4800 I HTR 1 C Y ---------------------------------------------------------------------------------------------------------------- 195 Surgery Retractor 878.4800 I GAD 1 C Y ---------------------------------------------------------------------------------------------------------------- 196 Surgery Retractor 878.4800 I HXM 1 C Y ---------------------------------------------------------------------------------------------------------------- 197 Surgery Saw 878.4800 I HSO 1 C Y ---------------------------------------------------------------------------------------------------------------- 198 Surgery Scalpel Blade 878.4800 I GES 1 C Y ---------------------------------------------------------------------------------------------------------------- 199 Surgery Scalpel Handle 878.4800 I GDZ 1 C Y ---------------------------------------------------------------------------------------------------------------- 200 Surgery Scissors 878.4800 I LRW 1 C Y ---------------------------------------------------------------------------------------------------------------- 201 Surgery Snare 878.4800 I GAE 1 C Y ---------------------------------------------------------------------------------------------------------------- 202 Surgery Spatula 878.4800 I GAF 1 C Y ---------------------------------------------------------------------------------------------------------------- 203 Surgery Staple Applier 878.4800 I GEF 2 C Y ---------------------------------------------------------------------------------------------------------------- 204 Surgery Stapler 878.4800 I GAG 2 C Y ---------------------------------------------------------------------------------------------------------------- 205 Surgery Stomach and 878.4800 I FHM 2 C Y Intestinal Suturing Apparatus ---------------------------------------------------------------------------------------------------------------- 206 Surgery Surgical Curette 878.4800 I FZS 1 C Y ---------------------------------------------------------------------------------------------------------------- 207 Surgery Surgical Cutter 878.4800 I FZT 1 C Y ---------------------------------------------------------------------------------------------------------------- 208 Surgery Surgical Knife 878.4800 I EMF 1 S Y ---------------------------------------------------------------------------------------------------------------- 209 Surgery Laser Powered 878.4810 II GEX 2 C N Instrument ---------------------------------------------------------------------------------------------------------------- [[Page 38083]] 210 Surgery Ac-Powered Motor 878.4820 I GEY 2 C Y ---------------------------------------------------------------------------------------------------------------- 211 Surgery Bit 878.4820 I GFG 1 C Y ---------------------------------------------------------------------------------------------------------------- 212 Surgery Bur 878.4820 I GFF, GEY 1 C Y ---------------------------------------------------------------------------------------------------------------- 213 Surgery Cardiovascular 878.4820 I DWH 1 C Y Surgical Saw Blade ---------------------------------------------------------------------------------------------------------------- 214 Surgery Chisel 878.4820 I KDG 1 C Y (Osteotome) ---------------------------------------------------------------------------------------------------------------- 215 Surgery Dermatome 878.4820 I GFD 1 C Y ---------------------------------------------------------------------------------------------------------------- 216 Surgery Electrically 878.4820 I DWI 2 C Y Powered Saw ---------------------------------------------------------------------------------------------------------------- 217 Surgery Pneumatic 878.4820 I GET 2 C Y Powered Motor ---------------------------------------------------------------------------------------------------------------- 218 Surgery Pneumatically 878.4820 I KFK 2 C Y Powered Saw ---------------------------------------------------------------------------------------------------------------- 219 Surgery Powered Saw and 878.4820 I HAB 2 C Y Accessories ---------------------------------------------------------------------------------------------------------------- 220 Surgery Saw Blade 878.4820 I GFA 1 C Y ---------------------------------------------------------------------------------------------------------------- 221 Surgery Nonpneumatic 878.5900 I GAX 1 N Y Tourniquet ---------------------------------------------------------------------------------------------------------------- 222 Surgery Pneumatic 878.5910 I KCY 1 N Y Tourniquet ---------------------------------------------------------------------------------------------------------------- 223 Surgery Endoscopic 888.4540 I HXJ 2 C Y Staplers ---------------------------------------------------------------------------------------------------------------- 224 Surgery Trocar 876.1500 II GCJ, DRC 3 C N 870.1390 ---------------------------------------------------------------------------------------------------------------- 225 Surgery Surgical Cutting 878.4800 I GDZ, GDX, 2 C Y Accessories 874.4420 GES, KBQ, KAS ---------------------------------------------------------------------------------------------------------------- 226 Surgery Electrosurgical 876.4300 II HAM, GEI, 2 C N Electrodes/ 878.4400 FAS Handles/Pencils ---------------------------------------------------------------------------------------------------------------- 227 Surgery Scissor Tips 878.4800 I LRW, HDK, 2 C Y 884.4520 HDJ, JZB, 874.4420 KBD ---------------------------------------------------------------------------------------------------------------- 228 Surgery Laser Fiber 878.4810 II GEX, EWG, 1 C N Delivery 874.4500 LLW, HQF, Systems 886.4390 HHR, HQB 884.4550 886.4690 ---------------------------------------------------------------------------------------------------------------- \1\ N means no. \2\ Y means yes. [dagger] Indicates a change since last publication. Dated: June 20, 2003. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 03-16109 Filed 6-25-03; 8:45 am] BILLING CODE 4160-01-S