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icotec Instrument, Pedicle System MIS 2/2, Container Lid 42-862-2

by Icotec

Ref 42-862-2Model Container

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number764017255iPSI0006AY Basic UDI-DI 07640172551240UDI-DIDate11 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07640172551240 UDI-DI Date15 Aug 2019ListedStatusListed 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  • Withdrawn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
VADER® Pedicle System VADER® Pedicle System MIS 2/2 Container Lid EUDAMED
icotec Instrument, Pedicle System MIS 2/2, Container Lid GUDID
Generic Name
Device sterilization/disinfection container, reusable
Model / Ref / Catalog
42-862-2, Container
Primary DI / UDI-DI
07640172551240
Basic UDI-DI
764017255iPSI0006AY
Direct Marketing DI
07640172551240
FDA Product Code
NKB
EMDN Code
L1109 Neurosurgery and spinal surgery instrument kits, reusable
GMDN Term
Device sterilization/disinfection container, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
888.3070
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 I
GUDID
Class II

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Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (22)

  • 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
  • Manufacturing Date: No