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Duraloc, Duraloc Bantam, Duraloc Option, Pinnacle, Pinnacle Bantam

by DePuy Ireland UC

Ref 2346-01-000, 2364-12-000

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0603295a004879G Basic UDI-DI Date23 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10603295119715 UDI-DI Date24 Sep 2018ListedStatusListed 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  • Withdrawn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
Duraloc, Duraloc Bantam, Duraloc Option, Pinnacle, Pinnacle Bantam EUDAMED
Duraloc, Duraloc Option EUDAMED
Apex GUDID
Generic Name
Surgical drill guide, reusable
Surgical screwdriver, reusable
Device Name
Screwdriver
Drill Guide
Model / Ref / Catalog
2346-01-000, 2364-12-000, 236412000, 234601000
Primary DI / UDI-DI
10603295119715, 10603295119999
Basic UDI-DI
0603295a004879G, 0603295a004859C
Direct Marketing DI
10603295119715
10603295119999
FDA Product Code
HWT, HXX
EMDN Code
L26, L0922
GMDN Term
Surgical drill guide, reusable
Surgical screwdriver, reusable
Device Class
Class I
Regulation Number
888.4800, 888.4540
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

Related devices

Category: Surgical screwdriver, reusable

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