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

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (KCT) (8) Needle, Hypodermic, Single Lumen (FMI) (2)

Premarket Exempt

Clear

ProView plus - H816PM13181 Catalog Number : PM1318-1

Device Description : Self-Sealing Sterilization Pouch/Packaging 13" X 18"

Device Class :

Duns Number: 095153714

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 200

ProView plus - H816PM13191 Catalog Number : PM1318-1

Device Description : Self-Sealing Sterilization Pouch/Packaging 13" X 18"

Device Class :

Duns Number: 095153714

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 200

ProView plus - H816PM24401 Catalog Number : PM2440-1

Device Description : Self Sealing Sterilization Pouch/Packaging 2 1/4" x 4"

Device Class :

Duns Number: 095153714

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 200

ProView plus - H816PM27901 Catalog Number : PM2790-1

Device Description : Self Sealing Sterilization Pouch/Packaging 2 3/4" X 9"

Device Class :

Duns Number: 095153714

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 200

ProView plus - H816PM35541 Catalog Number : PM3554-1

Device Description : Self-Sealing Sterilization Pouch/Packaging 3.5" X 5.25"

Device Class :

Duns Number: 095153714

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 200

ProView Plus - H816PM35901 Catalog Number : PM3590-1

Device Description : Self-Sealing Sterilization Pouch/Packaging 3.5" x 9"

Device Class :

Duns Number: 095153714

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 200

ProView plus - H816PM54101 Catalog Number : PM5410-1

Device Description : Self-Sealing Sterilization Pouch/Packaging 5.25" x 10"

Device Class :

Duns Number: 095153714

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 200

ProView plus - H816PM75131 Catalog Number : PM7513-1

Device Description : Self-Sealing Sterilization Pouch/Packaging 7.5" x 13"

Device Class :

Duns Number: 095153714

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 200

ProTector - H816PNS1001 Catalog Number : PNS100-1

Device Description : Needle Sheath Prop

Device Class :

Duns Number: 095153714

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 100

ProTector - H816PNS5001 Catalog Number : PNS500-1

Device Description : Needle Sheath Prop

Device Class :

Duns Number: 095153714

Premarket Exempt : No

Product Code : FMI

Prescription Use : No

Device Count : 500

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