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Oxford® 32-423400

by Biomet Orthopedics, Inc.

Ref 32-423400

Oxford 32-423400 is an orthopaedic implant-instrument extension adaptor (EU MDR Class I; FDA Class I; FDA product code HWT, Template) made by Biomet Orthopedics, Inc., registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI 889024ALL2E) and listed in FDA GUDID since 2 Apr 2021 (UDI-DI 00887868485954), active as of 7 Nov 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number889024ALL2E Basic UDI-DI 00887868485954UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868485954 UDI-DI Date2 Apr 2021ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 889024ALL2E registered 30 Oct 2026 Active
  • FDA GUDID UDI-DI 00887868485954 listed 2 Apr 2021 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00887868485954
  2. Registered EUDAMED 889024ALL2E

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  • Withdrawn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
Oxford®
Generic name
Orthopaedic implant-instrument extension adaptor, reusable
Device name
OFL IM Fem Alignment Adapter
Model / Ref / Catalog
32-423400
Primary DI / UDI-DI
00887868485954
Basic UDI-DI
889024ALL2E
Direct marketing DI
00887868485954
FDA product code
HWT
EMDN code
Z12130503 Orthopaedic surgical drills
GMDN term
Orthopaedic implant-instrument extension adaptor, reusable
Device class
Class I
Regulation number
888.4800
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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Properties

  • Sterilise before use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)