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Tissue Probe 994500111

by Biomet Orthopedics, Inc.

Ref 994500111

Tissue Probe 994500111 is a Class I device made by Biomet Orthopedics, Inc., registered in EUDAMED on 30 Oct 2026 (Basic UDI-DI 889024-ZB002017-EW) and listed in FDA GUDID since 15 Aug 2023 (UDI-DI 00887868561153), 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 Number889024-ZB002017-EW Basic UDI-DI 00887868561153UDI-DIDate30 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868561153 UDI-DI Date15 Aug 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 889024-ZB002017-EW registered 30 Oct 2026 Active
  • FDA GUDID UDI-DI 00887868561153 listed 15 Aug 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00887868561153
  2. Registered EUDAMED 889024-ZB002017-EW

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  • Withdrawn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
Tissue Probe
Generic name
Surgical implant template, reusable
Model / Ref / Catalog
994500111
Primary DI / UDI-DI
00887868561153
Basic UDI-DI
889024-ZB002017-EW
Direct marketing DI
00887868561153
FDA product code
HXB
EMDN code
L091104 Orthopaedic prostheses positioners, reusable
GMDN term
Surgical implant template, reusable
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 implant template, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE.

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)