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Holder Bone Graft Packing Prep Tamp Torque Limiting Handle Spreader Top Endplate Removal Tool Screwdriver Release Tool Spreader Top Shaft

by Synthes GmbH 14 variants

Ref 03.807.348Model XRL Instruments for Insertion and Extraction

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7611819a00168JP Basic UDI-DI 07611819406292UDI-DIDate10 Jul 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  • Withdrawn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
Holder Bone Graft Packing Prep Tamp Torque Limiting Handle Spreader Top Endplate Removal Tool Screwdriver Release Tool Spreader Top Shaft
Model / Reference
XRL Instruments for Insertion and Extraction, 03.807.348
Primary DI / UDI-DI
07611819406292
Basic UDI-DI
7611819a00168JP
Direct Marketing DI
07611819406292
EMDN Code
L091001 Instruments for insertion and extraction of materials for osteosynthesis, reusable
Device Class
Class I
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

  • Reusable
  • CMR Substance

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