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Angled Rod Bone Impactor Guiding Tube Holding Base Loading Station Loading Unit Module Packing Tamp Tube-to-Tube Clamp Table Clamp Targeting Device

by Synthes GmbH 7 variants

Ref 03.630.146, 68.628.323, 387.346, 03.815.023, 03.628.102, 396.999, 03.812.043, 03.647.970, 03.816.000, 03.617.970, 03.809.942, 387.353Model Non-Invasive Devices for Spine - Instrument

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, self-declared

Class I: no certifier involved

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 Number7611819a00035J3 Basic UDI-DI Date14 Jul 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Angled Rod Bone Impactor Guiding Tube Holding Base Loading Station Loading Unit Module Packing Tamp Tube-to-Tube Clamp Table Clamp Targeting Device
Model / Reference
Non-Invasive Devices for Spine - Instrument, 03.630.146, 68.628.323, 387.346, 03.815.023, 03.628.102, 396.999, 03.812.043, 03.647.970, 03.816.000, 03.617.970, 03.809.942, 387.353
Primary DI / UDI-DI
07611819588042, 07611819507562, 07611819141261, 07611819534827, 07611819475892, 07611819259065, 07611819405936, 07611819404465, 07612334216151, 07611819969766, 07611819386921, 07611819098985
Basic UDI-DI
7611819a00035J3
Direct Marketing DI
07611819588042
07611819507562
07611819141261
07611819534827
07611819259065
07611819405936
07611819404465
07612334216151
07611819969766
07611819386921
07611819098985
EMDN Code
Z12139099 Various orthopaedic and traumatology instruments - other
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

  • CMR Substance YesEUDAMEDNoEUDAMED

Other properties (12)

  • Sterile: No
  • Implantable: No
  • Reusable: 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