21 CFR No. |
Classification Name |
Product Code for Nonrepro-cessed Device |
Product Code for Reprocessed Device |
Product Code Name for Reprocessed Device |
Unclassified |
Oocyte Aspiration Needles |
MHK |
NMO |
Oocyte Aspiration Needles |
Unclassified |
Percutaneous Transluminal Angioplasty Catheter |
LIT |
NMM |
Transluminal Peripheral Angioplasty Catheter |
Unclassified |
Ultrasonic Surgical Instrument |
LFL |
NLQ |
Ultrasonic Scalpel |
868.5150 |
Anesthesia Conduction Needle |
BSP |
NNH |
Anesthetic Conduction Needle (with/without Introducer) |
868.5150 |
Anesthesia Conduction Needle |
MIA |
NMR |
Short Term Spinal Needle |
868.5730 |
Tracheal Tube |
BTR |
NMA |
Tracheal Tube (with/without connector) |
868.5905 |
Noncontinous Ventilator (IPPB) |
BZD |
NMC |
Noncontinuous Ventilator (Respirator Mask) |
870.1200 |
Diagnostic Intravascular Catheter |
DQO |
NLI |
Angiography Catheter |
870.1220 |
Electrode Recording Catheter |
DRF |
NLH |
Electrode Recording Catheter |
870.1220 |
Electrode Recording Catheter |
MTD |
NLG |
Intracardiac Mapping Catheter |
870.1230 |
Fiberoptic Oximeter Catheter |
DQE |
NMB |
Fiberoptic Oximeter Catheter |
870.1280 |
Steerable Catheter |
DRA |
NKS |
Steerable Catheter |
870.1290 |
Steerable Catheter Control System |
DXX |
NKR |
Steerable Catheter Control System |
870.1330 |
Catheter Guide Wire |
DQX |
NKQ |
Catheter Guide Wire |
870.1390 |
Trocar |
DRC |
NMK |
Cardiovascular Trocar |
870.1650 |
Angiographic Injector and Syringe |
DXT |
NKT |
Angiographic Injector and Syringe |
870.1670 |
Syringe Actuator for Injector |
DQF |
NKW |
Injector for Actuator Syringe |
870.2700 |
Oximeter |
MUD |
NMD |
Tissue Saturation Oximeter |
870.2700 |
Oximeter |
DQA |
NLF |
Oximeter |
870.3535 |
Intra-Aortic Balloon and Control System |
DSP |
NKO |
Intra-Aortic Balloon and Control System |
870.4450 |
Vascular Clamp |
DXC |
NMF |
Vascular Clamp |
870.4885 |
External Vein Stripper |
DWQ |
NLJ |
External Vein Stripper |
872.5470 |
Orthodontic Plastic Bracket |
DYW |
NLC |
Orthodontic Plastic Bracket |
874.4680 |
Bronchoscope (Flexible or Rigid) and Accessories |
BWH |
NLE |
Bronchoscope (Nonrigid Biopsy Forceps) |
876.1075 |
Gastro-Urology Biopsy Instrument |
FCG |
NMX |
G-U Biopsy Needle and Needle Set |
876.1075 |
Gastro-Urology Biopsy Instrument |
KNW |
NLS |
Biopsy Instrument |
876.1500 |
Endoscope and Accessories |
FBK, FHP |
NMY |
Endoscopic Needle |
876.1500 |
Endoscope and Accessories |
MPA |
NKZ |
Endoilluminator |
876.1500 |
Endoscope and Accessories |
GCJ |
NLM |
General and Plastic Surgery Laparoscope |
876.1500 |
Endoscope and Accessories |
FHO |
NLX |
Spring-Loaded Pneumoperitoneum Needle |
876.4300 |
Endoscopic Electrosurgical Unit and Accessories |
FAS |
NLW |
Active Urological Electrosurgical Electrode |
876.4300 |
Endoscopic Electrosurgical Unit and Accessories |
FEH |
NLV |
Flexible Suction Coagulator Electrode |
876.4300 |
Endoscopic Electrosurgical Unit and Accessories |
KGE |
NLU |
Electric Biopsy Forceps |
876.4300 |
Endoscopic Electrosurgical Unit and Accessories |
FDI |
NLT |
Flexible Snare |
876.4300 |
Endoscopic Electrosurgical Unit and Accessories |
KNS |
NLR |
Endoscopic (with or without accessories) Electrosurgical Unit |
876.5010 |
Biliary Catheter and Accessories |
FGE |
NML |
Biliary Catheter |
876.5540 |
Blood Access Device and Accessories |
LBW |
NNF |
Single Needle Dialysis Set (co-axial flow) |
876.5540 |
Blood Acces Device and Accessories |
FIE |
NNE |
Fistula Needle |
876.5820 |
Hemodialysis Systems and Accessories |
FIF |
NNG |
Single Needle Dialysis Set with Uni-Directional Pump |
878.4300 |
Implantable Clip |
FZP |
NMJ |
Implantable Clip |
878.4400 |
Electrosurgical Cutting and Coagulation Device and Accessories |
GEI |
NUJ |
Endoscopic and Laparoscopic Electrosurgical Accessories |
878.4750 |
Implantable Staple |
GDW |
NLL |
Implantable Staple |
880.5570 |
Hypodermic Single Lumen Needle |
FMI |
NKK |
Hypodermic Single Lumen Needle |
880.5860 |
Piston Syringe |
FMF |
NKN |
Piston Syringe |
882.4300 |
Manual Cranial Drills, Burrs, Trephines and Accessories |
HBG |
NLO |
(Manual) Drills, Burrs, Trephines, and Accessories |
882.4305 |
Powered Compound Cranial Drills, Burrs, Trephines |
HBF |
NLP |
(Powered, Compound) Drills, Burrs, Trephines and Accessories |
882.4310 |
Powered Simple Cranial Drills, Burrs, Trephines |
HBE |
NLN |
(Simple, Powered) Drills, Burrs, Trephines and Accessories |
884.1720 |
Gynecologic Laparoscope and Accessories |
HET |
NMH |
Gynecologic Laparoscope (and Accessories) |
884.6100 |
Assisted Reproduction Needle |
MQE |
NNB |
Assisted Reproduction Needle |
886.4370 |
Keratome |
HMY, HNO |
NKY |
Keratome Blade |
886.4670 |
Phacofragmentation System |
HQC |
NKX |
Phacoemulsification Needle |
892.5730 |
Radionuclide Brachytherapy Source |
IWF |
NMP |
Isotope Needle |
Hemodialyzers have been excluded from this list because the reuse of
hemodialyzers is addressed in "Draft Guidance for Hemodialyzer Reuse
Labeling" October 6, 1995. An archived copy may be obtained from
CDRH's Division of Small Manufacturers, International, and Consumer
Assistance, please contact dsmica@cdrh.fda.gov.