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Slotted Mallet w/Delrin Cap

by Symmetry Medical Manufacturing, Inc. EUDAMEDGUDID

Active European Union

Ref 10-102-400

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08475380323122C Basic UDI-DIDate31 Oct 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00847538007909 UDI-DIDate10 May 2022ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Generic Name
Surgical mallet
Model / Ref / Catalog
10-102-400, 2709-02-006, 00-9986-020-20, 430030
Primary DI / UDI-DI
00847538007909
Basic UDI-DI
08475380323122C
Direct Marketing DI
00847538007909
FDA Product Code
LXH
EMDN Code
L098099 Orthopaedic and traumatological surgery instruments, reusable - other accessories
GMDN Term
Surgical mallet
Device Class
Class I
Regulation Number
888.4540
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