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) (10)

Premarket Exempt

No Yes

Clear

SURGICOUNT - 37613327512800 Catalog Number : 0631-018-180

Device Description : + SAFE-T-Lap Sponge, 18 inch x 18 inch, RFID, X-Ray

Device Class :

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : Yes

Device Count : 5

SURGICOUNT - 37613327512817 Catalog Number : 0631-118-180

Device Description : + SAFE-T-Lap Sponge, 18 inch x 18 inch, RFID, X-Ray, Plastic Ring

Device Class :

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : Yes

Device Count : 5

SURGICOUNT - 37613327512824 Catalog Number : 0631-108-360

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

Device Class :

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : Yes

Device Count : 5

SURGICOUNT - 37613327512831 Catalog Number : 0631-218-180

Device Description : + SAFE-T-Lap Sponge, 18 inch x 18 inch, RFID, X-Ray, No Loop

Device Class :

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : Yes

Device Count : 5

SURGICOUNT - 37613327512848 Catalog Number : 0631-318-360

Device Description : + SAFE-T-Lap Sponge, 18 inch x 36 inch, RFID, X-Ray

Device Class :

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : Yes

Device Count : 3

SURGICOUNT - 37613327512855 Catalog Number : 0633-360-020

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

Device Class :

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : Yes

Device Count : 2

SURGICOUNT - 37613327512862 Catalog Number : 0633-160-020

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

Device Class :

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : Yes

Device Count : 2

SURGICOUNT - 37613327512879 Catalog Number : 0633-260-020

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

Device Class :

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : Yes

Device Count : 2

SURGICOUNT - 37613327513104 Catalog Number : 0633-260-050

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

Device Class :

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : Yes

Device Count : 5

SURGICOUNT - 37613327513111 Catalog Number : 0633-360-050

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

Device Class :

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : Yes

Device Count : 5

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