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Gauthier Biomedical

by Gauthier Biomedical, Inc. 50 variants

Ref G900100

Gauthier Biomedical (G900100) is a surgical instrument handle (EU MDD Class I; FDA Class I; FDA product code LXH, Orthopedic Manual Surgical Instrument) made by Gauthier Biomedical, Inc., registered in EUDAMED on 14 Jan 2026 (Basic UDI-DI B-00858325005015) and listed in FDA GUDID since 7 Aug 2020 (UDI-DI 00858325005015), active as of 22 Oct 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00858325005015 Basic UDI-DI 00858325005015UDI-DIDate14 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00858325005015 UDI-DI Date7 Aug 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00858325005015 registered 14 Jan 2026 Active
  • FDA GUDID UDI-DI 00858325005015 listed 7 Aug 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00858325005015
  2. Registered EUDAMED B-00858325005015

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  • Withdrawn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

Generic name
Surgical instrument handle, non-torque-limiting
Device name
T Handle, Ratchet
Model / Ref / Catalog
G900100
Primary DI / UDI-DI
00858325005015
Basic UDI-DI
B-00858325005015
FDA product code
LXH
EMDN code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN term
Surgical instrument handle, non-torque-limiting
Device class
Class I
Regulation number
888.4540
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
US-MF-000015766
Authorised representative
MDSS GmbH DE-AR-000005430

Similar devices in this category

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

Other devices from Gauthier Biomedical, Inc.

See all devices from Gauthier Biomedical, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (18, all answered No)