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Gamma 1320-0016S

by Stryker Corp.

Ref 1320-0016SModel 08858251003012RY

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251003012RY Basic UDI-DI 04546540661340UDI-DIDate28 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04546540661340 UDI-DI Date7 Apr 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Gamma3® EUDAMED
Gamma GUDID
Generic Name
Orthopaedic guidewire, reusable
Device Name
GAMMA3 Instruments - Guide-Wires, K-Wires, Pins - Class Iia - Sterile
Model / Ref / Catalog
1320-0016S, 08858251003012RY
Primary DI / UDI-DI
04546540661340
Basic UDI-DI
08858251003012RY
FDA Product Code
LXH
EMDN Code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN Term
Orthopaedic guidewire, reusable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
888.4540
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Length — 500.0 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Related devices

Category: Orthopaedic guidewire, reusable

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Sterile
  • Single Use
  • CMR Substance
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No