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510(k) Data Aggregation
K Number
K974188Device Name
CETYLCIDE-G
Manufacturer
Date Cleared
1998-09-10
(307 days)
Product Code
Regulation Number
880.6885Why did this record match?
Applicant Name (Manufacturer) :
KELLER AND HECKMAN
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Cetylcide-G is intended for use as a liquid chemical sterilant and/or a high level disinfectant to sterilize and disinfect medical devices and instruments in hospitals, medical, dental, and other healthcare facilities when used according to the directions for use in the package insert.
Sterilant: Cetylcide-G is a sterilant when mixed and used in accordance with its directions for use for a maximum of 28 days at 20°C with an immersion time of at least 10 hours at its minimum effective concentration (MEC) of 2.1% glutaraldehyde.
High Level Disinfectant: Cetylcide-G is a high level disinfectant when mixed and used according to its directions for use for a maximum of 28 days at 20°C with an immersion time of at least 40 minutes at its minimum effective concentration (MEC) of 2.1% glutaraldehyde.
Device Description
Concentrated glutaraldehyde solution for sterilization and high level disinfection (used with diluent solution)
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