STRYKER CORPORATION

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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

GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE (GDY) (5)

Premarket Exempt

No Yes

Clear

SURGICOUNT - 57613327513092 Catalog Number : 0623-260-020

Device Description : + OR Towel, Green, RFID, X-Ray, 2/Pack

Device Class : 1

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : Yes

Device Count : 400

SURGICOUNT - 57613327513122 Catalog Number : 0623-160-050

Device Description : + OR Towel, Blue, RFID, X-Ray, 5/Pack

Device Class : 1

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : Yes

Device Count : 400

SURGICOUNT - 57613327513139 Catalog Number : 0623-260-050

Device Description : + OR Towel, Green, RFID, X-Ray, 5/Pack

Device Class : 1

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : Yes

Device Count : 400

SURGICOUNT - 57613327513146 Catalog Number : 0623-360-050

Device Description : + OR Towel, White, RFID, X-Ray, 5/Pack

Device Class : 1

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : Yes

Device Count : 400

SURGICOUNT - 57613327513184 Catalog Number : 0621-008-360

Device Description : + SAFE-T-Lap Sponge, 8 inch x 36 inch, RFID, X-Ray

Device Class : 1

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : Yes

Device Count : 800

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