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X Osteotome, 7mm

by Symmetry Medical Manufacturing, Inc. 25 variants

Ref 11-007-000

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 Number08475380128442U Basic UDI-DI 00847538001112UDI-DIDate30 Oct 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00847538001112 UDI-DI Date11 May 2022ListedStatusListed 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  • Withdrawn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
Thin Osteotome Blade curve end 20mm
Generic Name
Orthopaedic osteotome
Device Name
“X” Osteotome, 7mm
Model / Ref / Catalog
11-007-000, 00-9986-021-25
Primary DI / UDI-DI
00847538001112
Basic UDI-DI
08475380128442U
Direct Marketing DI
00847538001112
FDA Product Code
GFI
EMDN Code
L090404 Osteotomes and scalpels blades, reusable
GMDN Term
Orthopaedic osteotome
Device Class
Class I
Regulation Number
878.4800
EU market of registration
France
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

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

Other properties (18)

  • Sterile: 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