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Mallet, Small

by Avalign Technologies Inc. EUDAMEDGUDID

Active European Union

Ref 03.520.024, 48970098, 48019301

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0190776MALLETQE Basic UDI-DIDate17 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00190776028329 UDI-DIDate15 Jan 2020ListedStatusListed 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  • Withdrawn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

Trade Name
Stryker
Depuy Synthes
Generic Name
Orthopaedic instrument extractor
Surgical mallet
Model / Reference
03.520.024, 48019301, 48970098
Primary DI / UDI-DI
00190776028329, 00190776138271, 00190776141318
Basic UDI-DI
0190776MALLETQE
Direct Marketing DI
00190776028329
00190776141318
00190776138271
FDA Product Code
LXH, GFJ
EMDN Code
L0903, L091199
GMDN Term
Orthopaedic instrument extractor
Surgical mallet
Device Class
Class I
Regulation Number
888.4540, 878.4800
Market of Registration
Bulgaria
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Manufacturer details

EUDAMED SRN
US-MF-000008511
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from AVALIGN TECHNOLOGIES, Inc.

See all devices from AVALIGN TECHNOLOGIES, Inc. →

Properties

  • Reusable
  • CMR Substance
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (19)

  • Sterile: No
  • Single Use: 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No