CARGUS INTERNATIONAL, INC

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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) (8) Wrap, Sterilization (FRG) (8) Cleanser, Root Canal (KJJ) (1) Tester, Pulp (EAT) (1)

Premarket Exempt

No Yes

Clear

MARK3 - D79659701 Catalog Number :

Device Description : Endo Pulp Vitality Refrigerant Spray 6oz. Bottle - MARK3®

Device Class : 2

Duns Number: 096191093

Premarket Exempt : Yes

Product Code : EAT

Prescription Use : Yes

Device Count : 1

MARK3 - D79659780 Catalog Number :

Device Description : Canal Prep Root Canal Preparation Cream 18gm. - MARK3

Device Class : U

Duns Number: 096191093

Premarket Exempt : No

Product Code : KJJ

Prescription Use : Yes

Device Count : 1

MARK3 - D79661100 Catalog Number :

Device Description : Self Seal 2-1/4" x 5" (2-1/4" x 4") Sterilization Pouches 200/bx. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : FRG, JOJ

Prescription Use : No

Device Count : 200

MARK3 - D7966110CS1 Catalog Number :

Device Description : Self Seal 2-1/4" x 5" (2-1/4" x 4") Sterilization Pouches 60/cs. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : FRG, JOJ

Prescription Use : No

Device Count : 60

MARK3 - D79661110 Catalog Number :

Device Description : Self Seal 2" x 9" (2" x 8") Sterilization Pouches 200/bx. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : FRG, JOJ

Prescription Use : No

Device Count : 200

MARK3 - D7966111CS1 Catalog Number :

Device Description : Self Seal 2" x 9" (2" x 8") Sterilization Pouches 10/cs. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : FRG, JOJ

Prescription Use : No

Device Count : 20

MARK3 - D79661120 Catalog Number :

Device Description : Self Seal 2-3/4" x 10"(2-3/4" x 9") Sterilization Pouches 200/bx. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : JOJ, FRG

Prescription Use : No

Device Count : 200

MARK3 - D796611200 Catalog Number :

Device Description : Self Seal 2-3/4" x 10"(2-3/4" x 9") Sterilization Pouches 200/bx. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : FRG, JOJ

Prescription Use : No

Device Count : 200

MARK3 - D7966112CS1 Catalog Number :

Device Description : Self Seal 2-3/4" x 10"(2-3/4" x 9") Sterilization Pouches 10/cs. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : FRG, JOJ

Prescription Use : No

Device Count : 20

MARK3 - D79661130 Catalog Number :

Device Description : Self Seal 3-1/2" x 6-1/2" (3-1/2" x 5-1/4") Sterilization Pouches 200/bx. - MARK3

Device Class : 2

Duns Number: 096191093

Premarket Exempt : No

Product Code : JOJ, FRG

Prescription Use : No

Device Count : 200

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