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Trial Spacer and Holder Assembly Disassembly Tool Push Block Spindle Insert Adjustable Stop Strike Cap T-Handle

by Synthes GmbH 5 variants

Ref 03.825.104, 03.815.035, 03.825.002, 03.825.101, 03.825.106, 03.825.105, 03.815.036, 03.815.029, 03.825.103, 03.815.037Model SynCage Evolution 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 25 Oct 2026. What this means

Overview

For medical device manufacturers and distributors, the Trial Spacer and Holder Assembly Disassembly Tool Push Block Spindle Insert Adjustable Stop Strike Cap T-Handle is a versatile instrument designed for optimal precision and safety in various medical procedures. This tool features adjustable stops, a striking mechanism, and an integrated spindle for efficient disassembly.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number7611819a00146JD Basic UDI-DI Date14 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  • Withdrawn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

Model / Reference
SynCage Evolution Instruments for Insertion and Extraction, 03.825.104, 03.815.035, 03.825.002, 03.825.101, 03.825.106, 03.825.105, 03.815.036, 03.815.029, 03.825.103, 03.815.037
Primary DI / UDI-DI
07611819538306, 07611819534520, 07611819542303, 07611819530676, 07611819538320, 07611819538313, 07611819534537, 07611819534513, 07611819530690, 07611819534544
Basic UDI-DI
7611819a00146JD
Direct Marketing DI
07611819538306
07611819534520
07611819542303
07611819530676
07611819538320
07611819538313
07611819534537
07611819534513
07611819530690
07611819534544
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 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