Pentax EB-1970TK Instructions For Use Manual page 59

High Level Disinfectants
The following liquid chemical germicides have received FDA 510(k) clearance for claims of
high level disinfection (HLD). Some HLD products may have multiple label claims and/or may
be FDA-cleared only for use in a legally marketed AER machine that can attain specific use
parameters (e.g., temperature).
Product Brand Name
Cidex ® OPA
®
Cidex OPA-C (used exclusively in EvoTech ECR)
®
Cidex Activated Dialdehyde Solution(14-Day
Glutaraldehyde)
®
MetriCide (Glutaraldehyde - may also be marketed
as Omnicide NS or MaxiCide
®
Sporicidin (Glutaraldehyde)
®
Rapicide (Glutaraldehyde)
®
Wavicide -01 (Glutaraldehyde)
Sterilization Agents/Processes
The following agents/processes have received FDA 510(k) clearance for claims of sterilization:
Ethylene Oxide / Carbon Dioxide (80:20 gas mixture)
Ethylene Oxide / Carbon Dioxide (90:10 gas mixture)
Advanced Sterilization Products
Metrex Research Corporation
®
NS)
Contec Incorporated
Medivators Inc.
Medical Chemical Corporation
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Manufacturer
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