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

Chair, Dental, With Operative Unit (KLC) (4) Indicator, Sterilization (LRT) (3) Mask, Surgical (FXX) (2) Sterilization Wrap Containers, Trays, Cassettes & Other Accessories (KCT) (1)

Premarket Exempt

Clear

Barrier - H816BB0312H1 Catalog Number : BB-0312H-1

Device Description : 3 x 12 instrument / equipment drape, chair sox

Device Class :

Duns Number: 095153714

Premarket Exempt : No

Product Code : KLC

Prescription Use : No

Device Count : 500

BARRIER - H816BB0528X1 Catalog Number : BB-0528X-1

Device Description : 5 x 28 Instrument / equipment drape, single-use, non-sterile x-ray sox

Device Class :

Duns Number: 095153714

Premarket Exempt : No

Product Code : KLC

Prescription Use : No

Device Count : 250

Barrier - H816BB2930C1 Catalog Number : BB-2930C-1

Device Description : 29 x 30 Instrument / equipment drape chair sox

Device Class :

Duns Number: 095153714

Premarket Exempt : No

Product Code : KLC

Prescription Use : No

Device Count : 200

Barrier - H816DC0115S1 Catalog Number : DC-0115S-1

Device Description : Disposable dental bib connnector with tape

Device Class :

Duns Number: 095153714

Premarket Exempt : No

Product Code : KLC

Prescription Use : No

Device Count : 300

Shield - H816PFL0081 Catalog Number : PFL008-1

Device Description : High-Efficiency Face Mask with Headband

Device Class :

Duns Number: 095153714

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

Shield - H816PFLEL81 Catalog Number : PFLEL8-1

Device Description : High-Efficiency Face Mask w/ Earloop

Device Class :

Duns Number: 095153714

Premarket Exempt : No

Product Code : FXX

Prescription Use : No

Device Count : 50

ProChek ID - H816PIT1001 Catalog Number : PIT100-1

Device Description : Steam Sterilization Indicator Tape

Device Class : 2

Duns Number: 095153714

Premarket Exempt : No

Product Code : LRT

Prescription Use : No

Device Count : 1

ProChek ID - H816PIT1201 Catalog Number : PIT120-1

Device Description : Steam Sterilization Indicator Tape

Device Class :

Duns Number: 095153714

Premarket Exempt : No

Product Code : LRT

Prescription Use : No

Device Count : 1

ProChek ID - H816PIT3401 Catalog Number : PIT340-1

Device Description : Steam Sterilization Indicator Tape

Device Class :

Duns Number: 095153714

Premarket Exempt : No

Product Code : LRT

Prescription Use : No

Device Count : 1

ProView plus - H816PM10161 Catalog Number : PM1016-1

Device Description : Self-Sealing Sterilization Pouch/Packaging 10" X 16"

Device Class :

Duns Number: 095153714

Premarket Exempt : No

Product Code : KCT

Prescription Use : No

Device Count : 200

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