Stryker Leibinger GmbH & Co. KG

Address:BOTZINGER STRASSE 39-41,FREIBURG Baden-Wurttemberg,DE

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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

ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES (GEI) (4) DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) (HBE) (3) ORTHOPEDIC MANUAL SURGICAL INSTRUMENT (LXH) (2) Orthopedic stereotaxic instrument (OLO) (1)

Premarket Exempt

Yes No

Clear

COLORADO - 04546540004192 Catalog Number : N117

Device Description : MicroDissection Needle

Device Class : 2

Duns Number: 316153956

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

COLORADO - 04546540004208 Catalog Number : N117A

Device Description : MicroDissection Needle

Device Class : 2

Duns Number: 316153956

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

COLORADO - 04546540004215 Catalog Number : N118

Device Description : MicroDissection Needle

Device Class : 2

Duns Number: 316153956

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

COLORADO - 04546540004222 Catalog Number : N118A

Device Description : MicroDissection Needle

Device Class : 2

Duns Number: 316153956

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

NA - 04546540012982 Catalog Number : 6003-100-090

Device Description : TRACKER ADAPTER

Device Class : 2

Duns Number: 316153956

Premarket Exempt : No

Product Code : OLO

Prescription Use : Yes

Device Count : 1

NA - 04546540133717 Catalog Number : 01-00770

Device Description : LINDEMANN BURR, LARGE

Device Class : 2

Duns Number: 316153956

Premarket Exempt : No

Product Code : HBE

Prescription Use : Yes

Device Count : 1

NA - 04546540133724 Catalog Number : 01-00780

Device Description : LINDEMANN BURR, MEDIUM

Device Class : 2

Duns Number: 316153956

Premarket Exempt : No

Product Code : HBE

Prescription Use : Yes

Device Count : 1

NA - 04546540133731 Catalog Number : 01-00790

Device Description : LINDEMANN BURR, SMALL

Device Class : 2

Duns Number: 316153956

Premarket Exempt : No

Product Code : HBE

Prescription Use : Yes

Device Count : 1

NA - 04546540133748 Catalog Number : 01-00930

Device Description : PERIOST. ELEVATOR, HENDERSON, SHARP

Device Class : 1

Duns Number: 316153956

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

MULTI-GUIDE - 04546540133946 Catalog Number : 01-01305

Device Description : BLADE FOR THREAD. PINS AND CLAMP. SCREWS

Device Class : 1

Duns Number: 316153956

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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