Skip to content

Quick-Coupling Handle for Flexible Osteotomes

by Symmetry Medical Manufacturing, Inc. 5 variants

Ref 15-628-000

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number084753804782954 Basic UDI-DI 00847538010954UDI-DIDate31 Oct 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00847538010954 UDI-DI Date19 May 2020ListedStatusListed GUDID: in commercial distribution

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
dePuy sythes
Generic Name
Surgical instrument handle, non-torque-limiting
Device Name
Quick-Coupling Handle for Flexible Osteotomes
Model / Ref / Catalog
15-628-000, 259807012
Primary DI / UDI-DI
00847538010954
Basic UDI-DI
084753804782954
Direct Marketing DI
00847538010954
FDA Product Code
LXH
EMDN Code
L098099 Orthopaedic and traumatological surgery instruments, reusable - other accessories
GMDN Term
Surgical instrument handle, non-torque-limiting
Device Class
Class I
Regulation Number
888.4540
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
US-MF-000025394
Authorised representative
SYMMETRY MEDICAL POLYVAC FR-AR-000003187

Other devices from Symmetry Medical Manufacturing, Inc.

See all devices from Symmetry Medical Manufacturing, Inc. →

Properties

  • Reusable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No