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

CAMERA, SURGICAL AND ACCESSORIES (KQM) (2) SURGICAL TABLE CUSHION (LWG) (1)

Premarket Exempt

No Yes

Clear

StrykeCam - 07613327488784 Catalog Number : P36000

Device Description : For F-Gen

Device Class : 1

Duns Number: 078807493

Premarket Exempt : Yes

Product Code : KQM

Prescription Use : No

Device Count : 1

StrykeCam - 07613327502046 Catalog Number : P45000

Device Description : For Visum LED

Device Class : 1

Duns Number: 078807493

Premarket Exempt : Yes

Product Code : KQM

Prescription Use : No

Device Count : 1

OPERON - 07613327589344 Catalog Number : OZ 7580275

Device Description : Pad Set 20" Leg, W Cutout, 3"

Device Class : 1

Duns Number: 078807493

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : Yes

Device Count : 1

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