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Handle 900716

by Biomet Orthopedics, Inc.

Ref 900716

Handle 900716 is a Class I device made by Biomet Orthopedics, Inc., registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI 889024ACBYU) and listed in FDA GUDID since 28 Jul 2017 (UDI-DI 00880304401655), 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 Number889024ACBYU Basic UDI-DI 00880304401655UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00880304401655 UDI-DI Date28 Jul 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 889024ACBYU registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI 00880304401655 listed 28 Jul 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00880304401655
  2. Registered EUDAMED 889024ACBYU

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  • Withdrawn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
Handle
Generic name
Surgical instrument handle, non-torque-limiting
Device name
Biomet Bone Dowel Handle
Model / Ref / Catalog
900716
Primary DI / UDI-DI
00880304401655
Basic UDI-DI
889024ACBYU
Direct marketing DI
00880304401655
FDA product code
LXH
EMDN code
Z12021199 Orthopaedic endoscopy instruments - other
GMDN term
Surgical instrument handle, non-torque-limiting
Device class
Class I
Regulation number
888.4540
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: Surgical instrument handle, non-torque-limiting

Similar devices in this category

Other devices filed under ORTHOPAEDIC ENDOSCOPY INSTRUMENTS - OTHER.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)