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KONG-C VBR System, Footprint Trial 18, 18x14 mm 43-061

by Icotec

Ref 43-061Model Footprint Trial

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number764017255iVBRC0007T8 Basic UDI-DI 07640172550632UDI-DIDate3 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07640172550632 UDI-DI Date19 Jun 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  • Withdrawn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
KONG®-C VBR System Footprint Trial 18, 18 x 14 mm EUDAMED
KONG-C VBR System, Footprint Trial 18, 18x14 mm GUDID
Generic Name
Surgical implant template, reusable
Model / Ref / Catalog
43-061, Footprint Trial
Primary DI / UDI-DI
07640172550632
Basic UDI-DI
764017255iVBRC0007T8
Direct Marketing DI
07640172550632
FDA Product Code
MQP, PLR
EMDN Code
L1109 Neurosurgery and spinal surgery instrument kits, reusable
GMDN Term
Surgical implant template, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
888.3060
EU 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
Device ClassEUDAMED
Class IIa
GUDID
Class II

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Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: 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
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No