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Offset Reamer Handle

by Viant Medical, LLC 2 variants

Ref T5766

Offset Reamer Handle (T5766) is a device classified as Class IIa in the EU and Class I in the US made by Viant Medical, LLC, registered in EUDAMED on 10 Dec 2025 (Basic UDI-DI B-00840096401752) and listed in FDA GUDID since 23 Oct 2020 (UDI-DI 00840096401752), 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-00840096401752 Basic UDI-DI 00840096401752UDI-DIDate10 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00840096401752 UDI-DI Date23 Oct 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00840096401752 registered 10 Dec 2025 Active
  • FDA GUDID UDI-DI 00840096401752 listed 23 Oct 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00840096401752
  2. Registered EUDAMED B-00840096401752

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  • Withdrawn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
Offset Reamer Handle EUDAMED
Viant Medical, LLC GUDID
Generic name
Surgical instrument handle, non-torque-limiting
Model / Ref / Catalog
T5766, 00-7804-080-00
Primary DI / UDI-DI
00840096401752
Basic UDI-DI
B-00840096401752
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 IIa EUDAMED
Class I GUDID
Regulation number
888.4540
EU registration type
Legacy device (under a directive)
EU market of registration
Estonia
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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.

Manufacturer details

EUDAMED SRN
US-MF-000042049
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 Viant Medical, LLC

See all devices from Viant Medical, LLC →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (17, all answered No)