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TraumaOne SYSTEM 46-1621

by Biomet Microfixation, Inc

Part of a family of 41 devices: see the family page

Ref 46-1621

TraumaOne SYSTEM 46-1621 is a Class I device made by Biomet Microfixation, Inc, registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI 889024AFS2A) and listed in FDA GUDID since 30 Jun 2020 (UDI-DI 00841036284749), 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 Number889024AFS2A Basic UDI-DI 00841036284749UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841036284749 UDI-DI Date30 Jun 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 889024AFS2A registered 23 Oct 2026 Active
  • FDA GUDID UDI-DI 00841036284749 listed 30 Jun 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00841036284749
  2. Registered EUDAMED 889024AFS2A

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  • Withdrawn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
TraumaOne SYSTEM
Generic name
Surgical instrument/implant rack
Device name
General Trays
Model / Ref / Catalog
46-1621
Primary DI / UDI-DI
00841036284749
Basic UDI-DI
889024AFS2A
FDA product code
LRP
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Surgical instrument/implant rack
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: Surgical instrument/implant rack

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Biomet Microfixation, Inc

See all devices from Biomet Microfixation, Inc →

Properties

  • Sterilise before use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)