Skip to content

Offset Cup Impactor

by Viant Medical, LLC EUDAMEDGUDID

Active European Union

Ref T8468

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00840096401288 Basic UDI-DIDate10 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00840096401288 UDI-DIDate14 May 2020ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Offset Cup Impactor EUDAMED
Viant Medical, LLC GUDID
Generic Name
Orthopaedic implant impactor, reusable
Model / Ref / Catalog
T8468
Primary DI / UDI-DI
00840096401288
Basic UDI-DI
B-00840096401288
FDA Product Code
HWA
EMDN Code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN Term
Orthopaedic implant impactor, reusable
Device Class
Class I
Regulation Number
888.4540
Market of Registration
Estonia
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
US-MF-000042049
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from Viant Medical, LLC

See all devices from Viant Medical, LLC →

Properties

  • Reusable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (17)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No