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Specialist 2

by DePuy Ireland UC 102 variants

Ref 96-6318

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0603295a002418E Basic UDI-DI 10603295247821UDI-DIDate23 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10603295247821 UDI-DI Date24 Mar 2015ListedStatusListed GUDID: in commercial distribution

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.

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  • Withdrawn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
Specialist 2 EUDAMED
Specialist GUDID
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable
Model / Ref / Catalog
96-6318, 966318
Primary DI / UDI-DI
10603295247821
Basic UDI-DI
0603295a002418E
Direct Marketing DI
10603295247821
FDA Product Code
HTZ
EMDN Code
L0922 Orthopaedic surgery guides, reusable
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device Class
Class I
Regulation Number
878.4800
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
IE-MF-000007377

Other devices from DePuy Ireland UC

See all devices from DePuy Ireland UC →

Properties

  • Reusable
  • CMR Substance
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

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