Plastcare USA

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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) Gauze / Sponge,Nonresorbable For External Use (NAB) (2)

Premarket Exempt

No Yes

Clear

Plastcare - D915RIT10161 Catalog Number :

Device Description : (10" x 16") Sterilization Pouches

Device Class :

Duns Number: 079299604

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 200

Plastcare - D915RIT12191 Catalog Number :

Device Description : (12" X 19") Sterilization Pouches

Device Class :

Duns Number: 079299604

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 200

Plastcare - D915RIT22041 Catalog Number :

Device Description : Gauze Non Woven Sponges 2 x 2 Inch.

Device Class :

Duns Number: 079299604

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 200

Plastcare - D915RIT23371 Catalog Number :

Device Description : (2 1/4" x 3 3/4") Sterilization Pouches

Device Class :

Duns Number: 079299604

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 200

Plastcare - D915RIT23501 Catalog Number :

Device Description : (2 1/4" x 5") Sterilization Pouches

Device Class :

Duns Number: 079299604

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 200

Plastcare - D915RIT23901 Catalog Number :

Device Description : (2 1/4" x 9'") Sterilization Pouches

Device Class :

Duns Number: 079299604

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 200

Plastcare - D915RIT27101 Catalog Number :

Device Description : (2 3/4" x 9") Sterilization Pouches

Device Class :

Duns Number: 079299604

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 200

Plastcare - D915RIT33041 Catalog Number :

Device Description : Gauze Non Woven Sponges 3 x 3 Inch.

Device Class :

Duns Number: 079299604

Premarket Exempt : Yes

Product Code : NAB

Prescription Use : No

Device Count : 200

Plastcare - D915RIT33121 Catalog Number :

Device Description : (3 1/4" x 12") Sterilization Pouches

Device Class :

Duns Number: 079299604

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 200

Plastcare - D915RIT35101 Catalog Number :

Device Description : (3 1/2" X 10") Sterilization Pouches

Device Class :

Duns Number: 079299604

Premarket Exempt : No

Product Code : JOJ

Prescription Use : No

Device Count : 200

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