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

Light, surgical, ceiling mounted (FSY) (4) TABLE, OPERATING-ROOM, AC-POWERED (FQO) (4) Endoscopic video imaging system/component, gastroenterology-urology (OCS) (2)

Premarket Exempt

No Yes

Clear

SwitchPoint Infinity, iSuite - 07613327054156 Catalog Number : 0678-001-000

Device Description : Infinity 3, Video Router

Device Class : 2

Duns Number: 078807493

Premarket Exempt : No

Product Code : OCS

Prescription Use : Yes

Device Count : 1

SwitchPoint Infinity, iSuite - 07613327054255 Catalog Number : 0678-003-000

Device Description : Infinity 3, Lite Video Router

Device Class : 2

Duns Number: 078807493

Premarket Exempt : No

Product Code : OCS

Prescription Use : Yes

Device Count : 1

NA - 07613327054286 Catalog Number : 0682000280

Device Description : Suspension, Navigation System, 10'

Device Class : 1

Duns Number: 078807493

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : Yes

Device Count : 1

NA - 07613327054293 Catalog Number : 0682000281

Device Description : Suspension, Navigation System

Device Class : 1

Duns Number: 078807493

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : Yes

Device Count : 1

Visum - 07613327054330 Catalog Number : 0682001252

Device Description : Surgical Light

Device Class : 2

Duns Number: 078807493

Premarket Exempt : Yes

Product Code : FSY

Prescription Use : Yes

Device Count : 1

Visum - 07613327054347 Catalog Number : 0682001253

Device Description : Surgical Light, Camera Ready

Device Class : 2

Duns Number: 078807493

Premarket Exempt : Yes

Product Code : FSY

Prescription Use : Yes

Device Count : 1

Visum - 07613327054415 Catalog Number : 0682400137

Device Description : Surgical Light, Low Ceiling

Device Class : 2

Duns Number: 078807493

Premarket Exempt : Yes

Product Code : FSY

Prescription Use : Yes

Device Count : 1

Visum - 07613327054422 Catalog Number : 0682400138

Device Description : Surgical Light, Camera Ready, Low Ceiling

Device Class : 2

Duns Number: 078807493

Premarket Exempt : Yes

Product Code : FSY

Prescription Use : Yes

Device Count : 1

NA - 07613327054514 Catalog Number : 0682-400-600

Device Description : Medium-Duty Dual Yoke

Device Class : 1

Duns Number: 078807493

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : Yes

Device Count : 1

NA - 07613327054521 Catalog Number : 0682-400-605

Device Description : Medium-Duty Suspension

Device Class : 1

Duns Number: 078807493

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : Yes

Device Count : 1

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