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 - D79661170 Catalog Number :

Device Description : Self Seal 5-1/4" x 7-1/2" (5 -1/4" x 6 -1/2") 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 - D796611705 Catalog Number :

Device Description : Self Seal 5-1/4" x 7-1/2" (5 -1/4" x 6 -1/2") 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 - D7966117CS1 Catalog Number :

Device Description : Self Seal 5-1/4" x 7-1/2" (5 -1/4" x 6 -1/2") Sterilization Pouches 10bxs/cs

Device Class : 2

Duns Number: 096191093

Premarket Exempt : No

Product Code : JOJ, FRG

Prescription Use : No

Device Count : 10

MARK3 - D7966117CS13 Catalog Number :

Device Description : Self Seal 5-1/4" x 7-1/2" (5 -1/4" x 6 -1/2") Sterilization Pouches 10/cs. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : FRG, JOJ

Prescription Use : No

Device Count : 10

MARK3 - D79661180 Catalog Number :

Device Description : Self Seal 5-1/4" x 11" (5-1/4" x 10") 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 - D796611806 Catalog Number :

Device Description : Self Seal 5-1/4" x 11" (5-1/4" x 10") 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 - D79661180CS1 Catalog Number :

Device Description : Self Seal 5-1/4" x 11" (5-1/4" x 10") Sterilization Pouches 10bxs/cs

Device Class : 2

Duns Number: 096191093

Premarket Exempt : No

Product Code : JOJ, FRG

Prescription Use : No

Device Count : 10

MARK3 - D7966118CS1 Catalog Number : 6118CS

Device Description : Self Seal 5-1/4" x 11" (5-1/4" x 10") Sterilization Pouches 15/cs. - MARK3

Device Class : 2

Duns Number: 096191093

Premarket Exempt : No

Product Code : JOJ, FRG

Prescription Use : No

Device Count : 15

MARK3 - D7966118CS14 Catalog Number :

Device Description : Self Seal 5-1/4" x 11" (5-1/4" x 10") Sterilization Pouches 15/cs. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : JOJ, FRG

Prescription Use : No

Device Count : 15

MARK3 - D79661190 Catalog Number :

Device Description : Self Seal 7-1/2" x 14" (7-1/2" x 13") 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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