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

SURGICAL TABLE CUSHION (LWG) (9) TABLE, OPERATING-ROOM, AC-POWERED (FQO) (1)

Premarket Exempt

No Yes

Clear

OPERON - 07613327395051 Catalog Number : OZ 7550875

Device Description : Surgical Table Pad, 3 Inch Seat with Cutouts

Device Class : 1

Duns Number: 078807493

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : Yes

Device Count : 1

OPERON - 07613327395068 Catalog Number : OZ 7561075

Device Description : Surgical Table Pad, 6 Inch Trigger Armboard

Device Class : 1

Duns Number: 078807493

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : Yes

Device Count : 1

OPERON - 07613327395075 Catalog Number : OZ 7554275

Device Description : Surgical Table Pad, 3 Inch Narrow Head Rest

Device Class : 1

Duns Number: 078807493

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : Yes

Device Count : 1

OPERON - 07613327395082 Catalog Number : OZ 7552275

Device Description : Surgical Table Pad, 3 Inch Shoulder Chair, Right

Device Class : 1

Duns Number: 078807493

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : Yes

Device Count : 1

OPERON - 07613327395099 Catalog Number : OZ 7569075

Device Description : Surgical Table Pad, 3 Inch Seat and Back with Cutouts, D8XX

Device Class : 1

Duns Number: 078807493

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : Yes

Device Count : 1

OPERON - 07613327395105 Catalog Number : OZ 7552675

Device Description : Surgical Table Pad, 3 Inch Trigger Armboard, Bariatric

Device Class : 1

Duns Number: 078807493

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : Yes

Device Count : 1

OPERON - 07613327395112 Catalog Number : OZ 7555775

Device Description : Surgical Table Pad, 3 Inch Split Back, Pair

Device Class : 1

Duns Number: 078807493

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : Yes

Device Count : 1

OPERON - 07613327395129 Catalog Number : OZ 7553075

Device Description : Surgical Table Pad, 3 Inch Adjustable Foot Extension, (12 Inch x 24 Inch)

Device Class : 1

Duns Number: 078807493

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : Yes

Device Count : 1

OPERON - 07613327395136 Catalog Number : OZ 7568875

Device Description : Surgical Table Pad, 3 Inch Rotational Vascular Arm

Device Class : 1

Duns Number: 078807493

Premarket Exempt : Yes

Product Code : LWG

Prescription Use : Yes

Device Count : 1

S-Series - 07613327400502 Catalog Number : 0682400550

Device Description : Equipment Management System

Device Class : 1

Duns Number: 078807493

Premarket Exempt : Yes

Product Code : FQO

Prescription Use : Yes

Device Count : 1

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