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1.0mm System 01-7446

by Biomet Microfixation, Inc

Ref 01-7446

1.0mm System 01-7446 is a Class I device made by Biomet Microfixation, Inc, registered in EUDAMED on 24 Oct 2026 (Basic UDI-DI B-00841036014292) and listed in FDA GUDID since 11 Apr 2017 (UDI-DI 00841036014292), active as of 7 Nov 2026.

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

CE MDD

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/MDD EUDAMED NumberB-00841036014292 Basic UDI-DI 00841036014292UDI-DIDate24 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841036014292 UDI-DI Date11 Apr 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00841036014292 registered 24 Oct 2026 Active
  • FDA GUDID UDI-DI 00841036014292 listed 11 Apr 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00841036014292
  2. Registered EUDAMED B-00841036014292

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
"""1.0mm"" System" EUDAMED
"1.0mm" System GUDID
Generic name
Surgical screwdriver, reusable
Device name
CranioFacial Instruments
Model / Ref / Catalog
01-7446
Primary DI / UDI-DI
00841036014292
Basic UDI-DI
B-00841036014292
FDA product code
HXX
EMDN code
L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
GMDN term
Surgical screwdriver, reusable
Device class
Class I
Regulation number
888.4540
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical screwdriver, reusable

Similar devices in this category

Other devices filed under INSTRUMENTS FOR INSERTION AND EXTRACTION OF MATERIALS FOR OSTEOSYNTHESIS, REUSABLE.

Other devices from Biomet Microfixation, Inc

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Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)