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) (8) Disinfectant, Medical Devices (LRJ) (1) Gauze/sponge, internal, x-ray detectable (GDY) (1)

Premarket Exempt

No Yes

Clear

Stryker SideKick Disinfecting Wipes - 37613327405263 Catalog Number :

Device Description : Disinfecting wipes

Device Class : 1

Duns Number: 078470558

Premarket Exempt : Yes

Product Code : LRJ

Prescription Use : No

Device Count : 1

SURGICOUNT - 37613327512589 Catalog Number : 0632-022-120

Device Description : + Gauze Sponge, 2 inch x 2 inch, 12 Ply, RFID, X-Ray

Device Class :

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : Yes

Device Count : 10

SURGICOUNT - 37613327512640 Catalog Number : 0632-244-160

Device Description : + Gauze Sponge, 4 inch x 4 inch, 16 Ply, RFID, Double X-Ray

Device Class :

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : Yes

Device Count : 10

SURGICOUNT - 37613327512664 Catalog Number : 0632-244-320

Device Description : + Gauze Sponge, 4 inch x 4 inch, 32 Ply, RFID, Double X-Ray

Device Class :

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : Yes

Device Count : 10

SURGICOUNT - 37613327512671 Catalog Number : 0632-284-160

Device Description : + Gauze Sponge, 8 inch x 4 inch, 16 Ply, RFID, Double X-Ray

Device Class :

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : Yes

Device Count : 10

SURGICOUNT - 37613327512688 Catalog Number : 0632-344-160

Device Description : + Gauze Sponge, 4 inch x 4 inch, 16 Ply, RFID, Double Wavy X-Ray

Device Class :

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : Yes

Device Count : 10

SURGICOUNT - 37613327512695 Catalog Number : 0632-284-240

Device Description : + Gauze Sponge, 8 inch x 4 inch, 24 Ply, RFID, Double X-Ray

Device Class :

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : Yes

Device Count : 10

SURGICOUNT - 37613327512770 Catalog Number : 0631-004-180

Device Description : + SAFE-T-Lap Sponge, 4 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 - 37613327512787 Catalog Number : 0631-012-120

Device Description : + SAFE-T-Lap Sponge, 12 inch x 12 inch, RFID, X-Ray

Device Class :

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : Yes

Device Count : 5

SURGICOUNT - 37613327512794 Catalog Number : 0631-008-360

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

Device Class :

Duns Number: 196548481

Premarket Exempt : Yes

Product Code : GDY

Prescription Use : Yes

Device Count : 5

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