STRYKER COMMUNICATIONS INC.

Address:571 Silveron Blvd.,Flower Mound,TX,75028,US

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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

TABLE, OPERATING-ROOM, AC-POWERED (FQO) (3) TABLE, OPERATING-ROOM, ELECTRICAL (GDC) (3) Light, surgical, ceiling mounted (FSY) (2) Endoscopic video imaging system/component, gastroenterology-urology (OCS) (1) SURGICAL TABLE CUSHION (LWG) (1)

Premarket Exempt

No Yes

Clear

NA - 07613327054538 Catalog Number : 0682-400-606

Device Description : Light-Duty Suspension

Device Class : 1

Duns Number: 078807493

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : Yes

Device Count : 1

Visum Blade - 07613327061178 Catalog Number : P22310

Device Description : Surgical Light Head Assembly, 5 Pole

Device Class : 2

Duns Number: 078807493

Premarket Exempt : Yes

Product Code : FSY

Prescription Use : Yes

Device Count : 1

Visum Blade, iSuite - 07613327061185 Catalog Number : P22309

Device Description : Visum Blade light Head Assembly, 9 Pole

Device Class : 2

Duns Number: 078807493

Premarket Exempt : Yes

Product Code : FSY

Prescription Use : Yes

Device Count : 1

NA - 07613327166712 Catalog Number : 0682000852

Device Description : Suspension, Single Universal Flat Panel, Ceiling, 10'

Device Class : 1

Duns Number: 078807493

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : Yes

Device Count : 1

NA - 07613327166736 Catalog Number : 0682000850

Device Description : Suspension, Single Universal Flat Panel, Ceiling, 9'

Device Class : 1

Duns Number: 078807493

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : Yes

Device Count : 1

OPERON - 07613327170474 Catalog Number : OZ 7518475

Device Description : Surgical Table, D750 D850 XRAY CASSETTE TRAY

Device Class : 1

Duns Number: 078807493

Premarket Exempt : Yes

Product Code : GDC

Prescription Use : Yes

Device Count : 1

Switchpoint Infinity - 07613327303605 Catalog Number : 0678-001-400

Device Class : 2

Duns Number: 078807493

Premarket Exempt : No

Product Code : OCS

Prescription Use : Yes

Device Count : 1

OPERON - 07613327354294 Catalog Number : OZ 7527675

Device Description : Surgical Table,INSIDE RAIL CLAMP

Device Class : 1

Duns Number: 078807493

Premarket Exempt : Yes

Product Code : GDC

Prescription Use : Yes

Device Count : 1

OPERON - 07613327354300 Catalog Number : OZ 7522875

Device Description : Surgical Table, IMAGING EXTENSION FILLER PLATE

Device Class : 1

Duns Number: 078807493

Premarket Exempt : Yes

Product Code : GDC

Prescription Use : Yes

Device Count : 1

OPERON - 07613327384505 Catalog Number : OZ 7559275

Device Description : Surgical Table Pad, 3 Inch Right Split Leg, Short

Device Class : 1

Duns Number: 078807493

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : Yes

Device Count : 1

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