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Tools - FPS GDUHP-1.8

by Trimed, INC.

Part of a family of 50 devices: see the family page

Ref GDUHP-1.8Model Reusable Surgical Instruments and Trays

Tools - FPS GDUHP-1.8 is a Class I device made by Trimed, INC., registered in EUDAMED on 3 Nov 2026 (Basic UDI-DI 08421881DRILLGUIDE3F) and listed in FDA GUDID since 20 Jan 2020 (UDI-DI 00842188121289), 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 Number08421881DRILLGUIDE3F Basic UDI-DI 00842188121289UDI-DIDate3 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842188121289 UDI-DI Date20 Jan 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 08421881DRILLGUIDE3F registered 3 Nov 2026 Active
  • FDA GUDID UDI-DI 00842188121289 listed 20 Jan 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00842188121289
  2. Registered EUDAMED 08421881DRILLGUIDE3F

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  • Withdrawn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
Reusable Surgical Instruments and Trays EUDAMED
Tools - FPS GUDID
Generic name
Surgical drill guide, reusable
Model / Ref / Catalog
GDUHP-1.8, Reusable Surgical Instruments and Trays
Primary DI / UDI-DI
00842188121289
Basic UDI-DI
08421881DRILLGUIDE3F
FDA product code
FZX
EMDN code
L0922 Orthopaedic surgery guides, reusable
GMDN term
Surgical drill guide, reusable
Device class
Class I
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical drill guide, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC SURGERY GUIDES, REUSABLE.

Other devices from Trimed, INC.

See all devices from Trimed, INC. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)