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) (7)

Premarket Exempt

No Yes

Clear

MARK3 - D796611907 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 : FRG, JOJ

Prescription Use : No

Device Count : 200

MARK3 - D7966119CS1 Catalog Number :

Device Description : Self Seal 7-1/2" x 14" (7-1/2" x 13") Sterilization Pouches 5bxs/cs

Device Class : 2

Duns Number: 096191093

Premarket Exempt : No

Product Code : JOJ, FRG

Prescription Use : No

Device Count : 5

MARK3 - D7966119CS15 Catalog Number :

Device Description : Self Seal 7-1/2" x 14" (7-1/2" x 13") Sterilization Pouches 5/cs. - MARK3

Device Class :

Duns Number: 096191093

Premarket Exempt : No

Product Code : FRG, JOJ

Prescription Use : No

Device Count : 5

MARK3 - D7966120CS1 Catalog Number :

Device Description : Self Seal 10" x 15" (10" x 14") Sterilization Pouches 5bxs/cs

Device Class : 2

Duns Number: 096191093

Premarket Exempt : No

Product Code : JOJ, FRG

Prescription Use : No

Device Count : 5

MARK3 - D79661210 Catalog Number :

Device Description : Self Seal 12" x 18" 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 - D7966121CS1 Catalog Number :

Device Description : Self Seal 12" x 18" Sterilization Pouches 200/bx. Case 3/Cs.– MARK3 ®

Device Class : 2

Duns Number: 096191093

Premarket Exempt : No

Product Code : JOJ, FRG

Prescription Use : No

Device Count : 200

MARK3 - D79661220 Catalog Number :

Device Description : Self Seal 10" x 15" (10" x 14") 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 - D79661250 Catalog Number :

Device Description : Sterilization Indicator Tape 1/2" 60 Yards 1/pk. - MARK3

Device Class : 2

Duns Number: 096191093

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

MARK3 - D7966125CS1 Catalog Number :

Device Description : Sterilization Indicator Tape 1/2" 60 Yards 76/cs. - MARK3

Device Class : 2

Duns Number: 096191093

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 76

MARK3 - D79661270 Catalog Number :

Device Description : Sterilization Indicator Tape 3/4" 60 Yards 1/pk.- MARK3

Device Class : 2

Duns Number: 096191093

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 1

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