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Gauthier Biomedical 5161-00-5002 (G908145)

by Gauthier Biomedical, Inc.

Ref 5161-00-5002

Gauthier Biomedical 5161-00-5002 (G908145) (5161005002) is an abdominal/ENT/orthopaedic surgical probe (EU MDR Class I; FDA Class I; FDA product code HXB, Probe) made by Gauthier Biomedical, Inc., registered in EUDAMED on 9 Jan 2026 (Basic UDI-DI 008583250055161-00-5002PT) and listed in FDA GUDID since 28 Nov 2023 (UDI-DI 00858325005442), active as of 22 Oct 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number008583250055161-00-5002PT Basic UDI-DI 00858325005442UDI-DIDate9 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00858325005442 UDI-DI Date28 Nov 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 008583250055161-00-5002PT registered 9 Jan 2026 Active
  • FDA GUDID UDI-DI 00858325005442 listed 28 Nov 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00858325005442
  2. Registered EUDAMED 008583250055161-00-5002PT

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  • Withdrawn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
Gauthier Biomedical
Generic name
Abdominal/ENT/orthopaedic surgical probe, reusable
Model / Ref / Catalog
5161-00-5002 EUDAMED
5161-00-5002 (G908145) GUDID
5161005002 GUDID
Primary DI / UDI-DI
00858325005442
Basic UDI-DI
008583250055161-00-5002PT
Direct marketing DI
00858325005442
FDA product code
HXB
EMDN code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN term
Abdominal/ENT/orthopaedic surgical probe, reusable
Device class
Class I
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
5161-00-5002
GUDID
5161-00-5002 (G908145)

Related devices

Category: Abdominal/ENT/orthopaedic surgical probe, reusable

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
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Measuring function
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (17, all answered No)