Skip to content

Connecting Bar Position Retainer Push Button Handle Screwdriver Holder Reduction Tool Length Indicator Guide Persuader Counter Torque Release Key Wrench Shaft Adapter Removal Instrument Sleeve Untightening Instrument Rod Indicator Slider

by Synthes GmbH EUDAMED

Active European Union

Ref 03.628.117, 03.628.115, 03.627.012, 03.631.538, 03.627.017, 03.627.024, 03.628.122, 03.631.537, 03.628.123, 03.628.129, 03.628.111, 03.628.108, 03.628.109, 03.628.120, 03.628.112, 03.628.105, 03.631.528, 03.628.124, 03.627.016, 03.628.119, 03.628.110Model USS Fracture MIS Instruments for Insertion and Extraction

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7611819a00210HV Basic UDI-DIDate11 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Model / Reference
USS Fracture MIS Instruments for Insertion and Extraction, 03.628.117, 03.628.115, 03.627.012, 03.631.538, 03.627.017, 03.627.024, 03.628.122, 03.631.537, 03.628.123, 03.628.129, 03.628.111, 03.628.108, 03.628.109, 03.628.120, 03.628.112, 03.628.105, 03.631.528, 03.628.124, 03.627.016, 03.628.119, 03.628.110
Primary DI / UDI-DI
07611819476035, 07611819476011, 07611819962408, 07611819603592, 07611819962453, 07611819962521, 07611819498600, 07611819603585, 07611819498617, 07611819665996, 07611819475977, 07611819475946, 07611819475953, 07611819494770, 07611819475984, 07611819475922, 07611819498112, 07611819504127, 07611819962446, 07611819476059, 07611819475960
Basic UDI-DI
7611819a00210HV
Direct Marketing DI
07611819476035
07611819476011
07611819962408
07611819603592
07611819962453
07611819962521
07611819498600
07611819603585
07611819498617
07611819665996
07611819475977
07611819475946
07611819475953
07611819494770
07611819475984
07611819475922
07611819498112
07611819504127
07611819962446
07611819476059
07611819475960
EMDN Code
L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
Device Class
Class I
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

  • Reusable
  • CMR Substance YesEUDAMEDNoEUDAMED

Other properties (11)

  • Sterile: 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