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Instrument 0935-0-054

by Howmedica Osteonics Corp.

Ref 0935-0-054Model 08858251004921TM

Instrument 0935-0-054 is a device classified as Class IIa in the EU and Class I in the US made by Howmedica Osteonics Corp., registered in EUDAMED on 14 Oct 2026 (Basic UDI-DI 08858251004921TM) and listed in FDA GUDID since 1 Dec 2016 (UDI-DI 17613327261056), 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 Number08858251004921TM Basic UDI-DI 17613327261056UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number17613327261056 UDI-DI Date1 Dec 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08858251004921TM registered 14 Oct 2026 Active
  • FDA GUDID UDI-DI 17613327261056 listed 1 Dec 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 17613327261056
  2. Registered EUDAMED 08858251004921TM

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  • Withdrawn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
Exeter EUDAMED
Instrument GUDID
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device name
TF-030 - Class IIa - Acetabular Cement Seals - Gamma
Model / Ref / Catalog
0935-0-054, 08858251004921TM
Primary DI / UDI-DI
17613327261056
Basic UDI-DI
08858251004921TM
FDA product code
LXH
EMDN code
P091399 Orthopaedic implant instruments, single-use - other
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC IMPLANT INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from Howmedica Osteonics Corp.

See all devices from Howmedica Osteonics Corp. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (20, all answered No)