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Gamma 1420-0300

by Stryker Corp.

Ref 1420-0300Model 08858251003278T8

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08858251003278T8 Basic UDI-DI 07613327510065UDI-DIDate28 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613327510065 UDI-DI Date28 Mar 2022ListedStatusListed 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  • Withdrawn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
Gamma4™ EUDAMED
Gamma GUDID
Generic Name
Orthopaedic surgical procedure kit, non-medicated, reusable
Device Name
Gamma 4 Instruments - Extraction Instrumentation - Class I - Reusable - Non Sterile
Model / Ref / Catalog
1420-0300, 08858251003278T8
Primary DI / UDI-DI
07613327510065
Basic UDI-DI
08858251003278T8
Direct Marketing DI
07613327510065
FDA Product Code
LXH
EMDN Code
P091280 Osteosynthesis devices, devices for tendon and ligament synthesis - accessories
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, reusable
Device Class
Class I
Regulation Number
888.4540
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic surgical procedure kit, non-medicated, reusable

Other devices from Stryker Corp.

See all devices from Stryker Corp. →

Properties

  • Reusable
  • CMR Substance
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Expiration Date: No
  • Manufacturing Date: No