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VERSALOOP™ 2.5mm Reusable Awl

by T.A.G. Medical products corporation LTD. EUDAMEDGUDID

Active European Union

Ref 514310mModel Versaloop System-Reusable Instruments

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number81012846VERSALOOPOREBH Basic UDI-DIDate22 Dec 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number10818674024928 UDI-DIDate3 Dec 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  • Withdrawn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

Generic Name
Ligament reconstruction instrument set, reusable
Device Name
VERSALOOP™ Straight Guide for 1.5mm Anchor, Fishmouth
Model / Ref / Catalog
Versaloop System-Reusable Instruments, 514310m, 210207
Primary DI / UDI-DI
10818674024928
Basic UDI-DI
81012846VERSALOOPOREBH
Direct Marketing DI
10818674024928
FDA Product Code
HWJ
EMDN Code
L0299 Suture instruments, reusable - other
GMDN Term
Ligament reconstruction instrument set, reusable
Device Class
Class I
Regulation Number
888.4540
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Versaloop System-Reusable Instruments
514310m
GUDID
210207

Manufacturer details

EUDAMED SRN
IL-MF-000029151
Authorised representative
MedNet EC-REP IIb GmbH DE-AR-000011192

Other devices from T.A.G. Medical products corporation LTD.

See all devices from T.A.G. Medical products corporation LTD. →

Properties

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

Other properties (20)

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