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510(k) Data Aggregation
K Number
K972708Device Name
ENDO-SPOR PLUS / HYPROCIDE
Manufacturer
COTTRELL, LTD.
Date Cleared
1999-09-13
(784 days)
Product Code
MED
Regulation Number
880.6885Why did this record match?
Applicant Name (Manufacturer) :
COTTRELL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Endo-Spor Plus™ liquid chemical germicide is intended for the disinfection and sterilization of endoscopic instruments and other heat labile medical and dental instruments.
Endo-Spor Plus™Hyprocide™is a chemical disinfecting and sterilization solution for use on flexible lensed endoscopy instruments, inhalation therapy equipment and instruments and materials that cannot be heat sterilized.
Device Description
The liquid chemical germicide Endo-Spor Plus™ contains the active ingredients hydrogen peroxide and peracetic acid. The germicide can be used as a high level disinfectant with a contact time of 15 minutes at 20℃ under reuse conditions of up to 14 days.
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K Number
K970726Device Name
VAPOCIDE
Manufacturer
COTTRELL, LTD.
Date Cleared
1998-05-18
(444 days)
Product Code
MED
Regulation Number
880.6885Why did this record match?
Applicant Name (Manufacturer) :
COTTRELL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Vapocide" is a sterilant solution intended to be used only in the Harvey Chemiclave Sterilizer to sterilize medical and dental surgical instruments and equipment. Vapocide is intended to be a direct substitute for Vapo-Sterli. Vapocide is recomended for use in the following Chemiclave series sterilizer models: Model E, 4000, 5000, 5500, 6000, EM 5000, EM 5500, EM 6000, 6000, 7000, 8000, and in Chemiclave cycle parameters as follows. Model E, 4000, 5000, 5500, 6000, EM 5000, EM 5500, EM 6000, - Operating pressure: 20-40 psi (1.41-2.82 kg/cm²) - Temperature: 132 ± 2°C (270 ± 5°F) - Maximum load: models with 8 and 10 in. diameter chambers Model 7000 and 8000 - Operating pressure: approximately 25 psi - Operating Temperature: 132 + 6, -0°C - Maximum load: 3.3 pounds (1.5 kg) Vapocide is compatible with but not limited to the following material types; - Surgical and cutting instruments, handpieces, and similar items - Plastic materials recommended are: Polysulfone, Phenolic, Epoxy, Polyphenylene, Oxide, Polyester, Polypropylene Vapocide" is not compatible with the following materials: - Linen, textiles or fabrics - Liquids and agars - Items contained in tightly woven packs or wraps - Plastics that cannot tolerate temperature in excess of 132ºC (270ºF) - Nylon tubing & bags inhibit penetration of chemical vapors Vapocide is not recommended for use for "flash" sterilization cycles.
Device Description
Vapocide™ is a liquid sterilant solution designed for use in Harvey Chemiclave sterilizers only. Vapocide™ and the Harvey Chemiclave function as a sustem to sterilize medical and dental surgical instruments and equipment. Vapocide™ is a sterilant solution intended to be used in the Harvey Chemiclave which is a unsaturated chemical vapor sterilizer. Unsaturated chemical vapor sterilizers function by using heat, water, and chemical synergism to sterilize medical and dental equipment. Vapocide™ is made of formaldehyde and ethanol. This formulation when heated under pressure, results in a relatively unsaturated and totally effective sterilization vapor which does not have deleterious effects one mark surfaces.
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K Number
K960089Device Name
PROCHEK G GLUTARALDEHYDE CONCENTRATION LEVEL INDICATOR
Manufacturer
COTTRELL, LTD.
Date Cleared
1996-04-04
(84 days)
Product Code
JOJ
Regulation Number
880.2800Why did this record match?
Applicant Name (Manufacturer) :
COTTRELL, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cottrell, Ltd., ProChek® G Glutaraldehyde Concentration Level Indicator is a 1.5% minimum effective concentration (MEC) monitor intended for use in 2-3.5% activated glutaraldehyde solutions.
Device Description
The ProChek® G Glutaraldehyde Concentration Level Indicator is a chemical indicator strip with a minimum effective concentration of 1.5% glutaraldehyde designed to monitor solutions, containing up to 3.5% activated glutaraldehyde. The indicator pad changes from yellow to purple, indicating a pass, if the active glutaraldehyde concentration in the solution being tested is greater than or equal to 1.75%.
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