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Dhs|dcs

by Synthes GmbH 12 variants

Ref 338.302, 338.310, 338.000S, 338.300, 681.340, 338.190, 338.260, 338.250, 338.140, 681.325Model Orthopaedic Wrenches, Orthopaedic Insertion and Extraction Instruments, Orthopaedic Wires Power Driven Stainless Steel - Single Use, Cases for Trauma/ CMF Devices, Orthopaedic Sleeves and Drill Guide

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7611819a00097JR Basic UDI-DI Date3 Nov 2025RegisteredStatusActive

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

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Orthopaedic Wrenches
Orthopaedic Insertion and Extraction Instruments
Orthopaedic Wires Power Driven Stainless Steel - Single Use
Cases for Trauma/ CMF Devices
Orthopaedic Sleeves and Drill Guide
Model / Reference
Orthopaedic Wrenches, 338.302, Orthopaedic Insertion and Extraction Instruments, 338.310, Orthopaedic Wires Power Driven Stainless Steel - Single Use, 338.000S, 338.300, Cases for Trauma/ CMF Devices, 681.340, Orthopaedic Sleeves and Drill Guide, 338.190, 338.260, 338.250, 338.140, 681.325
Primary DI / UDI-DI
07611819203235, 07611819022133, 07611819898837, 07611819022126, 07611819072831, 07611819022058, 07611819022102, 07611819022096, 07611819022027, 07611819088696
Basic UDI-DI
7611819a00097JR, 7611819a00219JF, 7611819a00556K4, 7611819a00012HP, 7611819a00225JA
Direct Marketing DI
07611819203235
07611819022133
07611819022126
07611819072831
07611819022058
07611819022102
07611819022027
07611819088696
EMDN Code
L091001, L091099, Z12130599, Z12011399
Device Class
Class I
Class IIa
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
CH-MF-000013345
Authorised representative
DePuy Ireland UC IE-AR-000009328

Other devices from Synthes GmbH

See all devices from Synthes GmbH →

Properties

  • Sterile NoEUDAMEDYesEUDAMED
  • Reusable YesEUDAMEDNoEUDAMED
  • CMR Substance YesEUDAMEDNoEUDAMED

Other properties (10)

  • 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