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Premier™ Instruments 32-487552

by Biomet Orthopedics, Inc.

Ref 32-487552

Premier™ Instruments 32-487552 is a Class I device made by Biomet Orthopedics, Inc., registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI 889024BGCZF) and listed in FDA GUDID since 8 May 2022 (UDI-DI 00887868496493), 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 Number889024BGCZF Basic UDI-DI 00887868496493UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868496493 UDI-DI Date8 May 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 889024BGCZF registered 30 Oct 2026 Active
  • FDA GUDID UDI-DI 00887868496493 listed 8 May 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00887868496493
  2. Registered EUDAMED 889024BGCZF

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  • Withdrawn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
Premier™ Instruments
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
Vanguard Premier Over The Top EM Tibial Guide
Model / Ref / Catalog
32-487552
Primary DI / UDI-DI
00887868496493
Basic UDI-DI
889024BGCZF
Direct marketing DI
00887868496493
FDA product code
FZX
EMDN code
L090999 Orthopaedic surgery cutting instruments, reusable - other
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class I
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (19, all answered No)