FDA-Cleared Sterilants and High Level Disinfectants with General Claims for Processing Reusable Medical and Dental Devices - September 28, 2006 |
Manufacturer |
Active Ingredient(s) |
Sterilant Contact Conditions |
High Level |
---|---|---|---|
K051305 TD-5 High-level Disinfectant |
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CS Medical, L.L.C. |
2.65% glutaraldehyde |
No indication for device sterilization. Passes the AOAC Sporicidal Activity Test in 10 hrs at 22 °C. |
5 min at 37.8ºC |
K041984 Acecide™ High Level Disinfectant and Sterilant | |||
Minntech Corp | 8.3% hydrogen peroxide 7.0% peracetic acid |
Indication for device sterilization. 5 hrs at 25°C |
5 min at 25°C 5 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes |
K041360 Aldahol III High Level Disinfectant | |||
Healthpoint LTD | 3.4% glutaraldehyde 26% isopropanol |
Indication for device sterilization. 10 hrs at 20° C |
10 min at 20ºC 14 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes. |
K012889? Banicide? Advanced for Sterilization and High Level Disinfection | |||
Pascal Company, Inc. | 3.5% glutaraldehyde | Indication for device sterilization.? 10
hrs at 25?C |
45 min at 25?C 30 days Maximum Reuse Contact conditions established by simulated use testing with endoscopes. |
K032959 Cidex® OPA Concentrate | |||
Advanced Sterilization Products | 5.75% ortho-phthaldehyde (OPA) | No indication for device sterilization. In-Use solution (0.05% OPA) passes the AOAC Sporicidal Activity Test in 32 hrs at 50°C. |
5 min at 50ºC Single use – diluted by system For use in the EvoTech Integrated Endoscope Disinfection System only. Contact conditions established by simulated use testing with endoscopes. |
K030004? Cidex? OPA Solution | |||
Advanced Sterilization Products |
0.55% ortho-phthaldehyde |
No indication for device sterilization. Passes the AOAC Sporicidal Activity Test in 32 hrs at 20?C and 25?C. |
Manual Processing Automated Endoscope Reprocessor (AER) |
K013280?? Sterilox Liquid High Level Disinfectant System | |||
Sterilox, Technologies, Inc. | Hypochlorite and Hypochlorous acid 650-675 ppm Active free chlorine |
No indication for device sterilization. Passes the Modified AOAC Sporicidal Activity Test in 24 hrs at 25?C. | 10 min at 25?C Single use - generated on site Contact conditions established by simulated use testing with endoscopes. |
K003087 ??Sporicidin Sterilizing and Disinfecting Solution | |||
Sporicidin International |
1.12% glutaraldehyde |
Indication for device sterilization. |
20 min at 25?C |
K993042?? Rapicide? High Level Disinfectant and Sterilant | |||
MediVators, Inc. |
2.5% glutaraldehyde |
Indication for device sterilization. |
Automated Endoscope Reprocessor
|
K991487 ??Cidex®OPA Solution High Level Disinfectant | |||
Advanced Sterilization Products |
0.55% ortho-phthaldehyde |
No indication for device sterilization.? Passes the AOAC Sporicidal Activity Test in 32 hrs at 20?C. |
12 min at 20?C |
K974188 ??Cetylcide-G? Concentrate and Diluent Concentrate | |||
Cetylite Industries, Inc. |
3.2% glutaraldehyde |
Indication for device sterilization. |
40 min at 20?C |
K974062? ?MedSci 3% Glutaraldehyde | |||
MedSci, Inc. |
3% glutaraldehyde |
Indication for device sterilization.
10 hrs at 25?C |
25 min at 25?C |
K972708??
EndoSpor? Plus Sterilizing and Disinfecting Solution Note: Due to the lack of test strips for monitoring the concentrations of the active ingredients, the reuse period is limited to 14 days. |
|||
Cottrell Limited |
7.35% hydrogen peroxide |
Indication for device sterilization. |
15 min at 20?C |
K970230?? SporoxTM Sterilizing & Disinfection Solution | |||
Reckitt & Colman Inc. |
7.5% hydrogen peroxide |
Indication for device sterilization. |
30 min at 20?C |
K960513?? PeractTM 20 Liquid Sterilant/Disinfectant | |||
Minntech Corporation |
1.0% hydrogen peroxide |
Indication for device sterilization. |
25 min at 20?C |
K932922?? Procide? 14 N.S. | |||
Cottrell Limited |
2.4% glutaraldehyde |
Indication for device sterilization. |
45 min at 20?C |
K932922 ??OmnicideTM Long Life Activated Dialdehyde Solution | |||
Cottrell Limited |
2.4% glutaraldehyde |
Indication for device sterilization. |
45 min at 20?C |
K932922?? OmnicideTM Plus | |||
Cottrell Limited |
3.4% glutaraldehyde |
Indication for device sterilization. |
45 min at 20?C |
K931592? ?Metricide Plus 30? Long-Life Activated Dialdehyde Solution | |||
Metrex Research, Inc. |
3.4% glutaraldehyde |
Indication for device sterilization. |
90 min at 25?C |
K931052?? Metricide? 28 Long-Life Activated Dialdehyde Solution | |||
Metrex Research, Inc. |
2.5% glutaraldehyde |
Indication for device sterilization. |
90 min at 25?C |
K930284?? Metricide? Activated Dialdehyde Solution |
|||
Metrex Research, Inc. |
2.6% glutaraldehyde |
Indication for device sterilization. |
45 min at 25?C |
K924434?? Cidex™ Activated Dialdehyde Solution |
|||
Johnson & Johnson Medical Products |
2.4% glutaraldehyde |
Indication for device sterilization. |
45 min at 25?C |
K924334 ??Cidex Formula 7™ Long-Life Activated Dialdehyde Solution |
|||
Johnson & Johnson Medical Products |
2.5% glutaraldehyde |
Indication for device sterilization. |
90 min at 25?C |
K923744?? Cidex PlusTM 28 Day Solution |
|||
Johnson & Johnson Medical Products |
3.4% glutaraldehyde |
Indication for device sterilization. |
20 min at 25?C |
K914749?? Wavicide? - 01 |
|||
Wave Energy Systems |
2.5% glutaraldehyde? |
Indication for device sterilization. |
45 min at 22?C |
K875280??
STERIS 20TM Sterilant Note: Cleared for use with the STERIS System 1TM Processor only. |
|||
STERIS? Corporation |
0.2% peracetic acid |
Indication for device sterilization. |
No indication for high level disinfection. |
Updated September 28, 2006
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