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9626-50-000

by Depuy (Ireland)

Ref 962650000Model MARATHON XLPE Acetabular Cup Trial Prosthesis

9626-50-000 (962650000) is a device classified as Class IIa in the EU and Class I in the US made by Depuy (Ireland), registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI 0603295a0005289) and listed in FDA GUDID since 24 Sep 2018 (UDI-DI 10603295243663), 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 Number0603295a0005289 Basic UDI-DI 10603295243663UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10603295243663 UDI-DI Date24 Sep 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0603295a0005289 registered 28 Oct 2026 Active
  • FDA GUDID UDI-DI 10603295243663 listed 24 Sep 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10603295243663
  2. Registered EUDAMED 0603295a0005289

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  • Withdrawn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
Marathon
Generic name
Acetabulum prosthesis trial, prefabricated, reusable
Device name
Acetabular Cup Trial Prosthesis
Model / Ref / Catalog
MARATHON XLPE Acetabular Cup Trial Prosthesis, 962650000, 9626-50-000
Primary DI / UDI-DI
10603295243663
Basic UDI-DI
0603295a0005289
FDA product code
HWT
EMDN code
L091199 Orthopaedic prosthetics instruments, reusable - other
GMDN term
Acetabulum prosthesis trial, prefabricated, reusable
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
888.4800
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
MARATHON XLPE Acetabular Cup Trial Prosthesis
962650000
GUDID
9626-50-000
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: Acetabulum prosthesis trial, prefabricated, reusable

Similar devices in this category

Other devices filed under ORTHOPAEDIC PROSTHETICS INSTRUMENTS, REUSABLE - OTHER.

Other devices from Depuy (Ireland)

See all devices from Depuy (Ireland) →

Properties

  • Sterilise before use
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)