CERTOL INTERNATIONAL, LLC

Address:6120 E. 58TH AVE.,Commerce City,CO,80022,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Indicator, Physical/Chemical Sterilization Process (JOJ) (1) Indicator, Sterilization (LRT) (1) Sterilant, Medical Devices (MED) (1)

Premarket Exempt

Clear

ProChek ID - H816SM43401 Catalog Number : SM4340-1

Device Description : Indicator Strips for Steam and Chemical Vapor

Device Class :

Duns Number: 095153714

Premarket Exempt : No

Product Code : LRT

Prescription Use : No

Device Count : 250

ProChek S - H816TSI4401 Catalog Number : TSI440-1

Device Description : Steam Sterilization Integrators

Device Class :

Duns Number: 095153714

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 100

V-Cide - H816VC3380 Catalog Number : VC338-1

Device Description : Formaldehyde Device Sterilant

Device Class : 2

Duns Number: 095153714

Premarket Exempt : No

Product Code : MED

Prescription Use : No

Device Count : 1

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