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) (10) Wrap, Sterilization (FRG) (10)

Premarket Exempt

No Yes

Clear

MARK3 - D796611301 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 : FRG, JOJ

Prescription Use : No

Device Count : 200

MARK3 - D7966113CS1 Catalog Number :

Device Description : Self Seal 3-1/2" x 6-1/2" (3-1/2" x 5-1/4") Sterilization Pouches 20/cs. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : FRG, JOJ

Prescription Use : No

Device Count : 20

MARK3 - D79661140 Catalog Number :

Device Description : Self Seal 3-1/2" x 10" (3-1/2" x 9") Sterilization Pouches 200/bx. - MARK3

Device Class : 2

Duns Number: 096191093

Premarket Exempt : No

Product Code : JOJ, FRG

Prescription Use : No

Device Count : 200

MARK3 - D796611402 Catalog Number :

Device Description : Self Seal 3-1/2" x 10" (3-1/2" x 9") Sterilization Pouches 200/bx. - MARK3

Device Class : 2

Duns Number: 096191093

Premarket Exempt : No

Product Code : FRG, JOJ

Prescription Use : No

Device Count : 200

MARK3 - D7966114CS1 Catalog Number :

Device Description : Self Seal 3-1/2" x 10" (3-1/2" x 9") Sterilization Pouches 10bxs/cs

Device Class : 2

Duns Number: 096191093

Premarket Exempt : No

Product Code : JOJ, FRG

Prescription Use : No

Device Count : 10

MARK3 - D7966114CS10 Catalog Number :

Device Description : Self Seal 3-1/2" x 10" (3-1/2" x 9") Sterilization Pouches 20/cs. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : FRG, JOJ

Prescription Use : No

Device Count : 20

MARK3 - D79661150 Catalog Number :

Device Description : Self Seal 3-1/4" x 12"(3-1/4" x 11") Sterilization Pouches 200/bx. - MARK3®

Device Class : 2

Duns Number: 096191093

Premarket Exempt : No

Product Code : JOJ, FRG

Prescription Use : No

Device Count : 200

MARK3 - D79661151 Catalog Number :

Device Description : Self Seal 3-1/4" x 12"(3-1/4" x 11") Sterilization Pouches 200/bx. Case 10/cs. - MARK3®

Device Class : 2

Duns Number: 096191093

Premarket Exempt : No

Product Code : JOJ, FRG

Prescription Use : No

Device Count : 200

MARK3 - D79661160 Catalog Number :

Device Description : Self Seal 4-1/4" x 12"(4-1/2" x 11") Sterilization Pouches 200/bx.– MARK3 ®

Device Class : 2

Duns Number: 096191093

Premarket Exempt : No

Product Code : JOJ, FRG

Prescription Use : No

Device Count : 200

MARK3 - D7966116CS1 Catalog Number :

Device Description : Self Seal 4-1/4" x 12"(4-1/2" x 11") Sterilization Pouches 200/bx.Case 10/Cs. – MARK3 ®

Device Class : 2

Duns Number: 096191093

Premarket Exempt : No

Product Code : JOJ, FRG

Prescription Use : No

Device Count : 200

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