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Guide Pins/Screws single use

by Gebr. Brasseler GmbH & Co. KG

Ref GP004.076.030.M4

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 2 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++E226533034SQV Basic UDI-DI 14053613298657UDI-DIDate14 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number14053613298657 UDI-DI Date14 Oct 2026ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 2 Nov 2026.

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  • Withdrawn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
Komet Guide Pin/Screw
Generic Name
Orthopaedic intraoperative positioning pin, single-use
Device Name
Guide Pins/Screws single use
Model / Ref / Catalog
GP004.076.030.M4, GP004.076.030
Primary DI / UDI-DI
14053613298657
Basic UDI-DI
++E226533034SQV
Unit of Use DI
84053613298656
510(k) Number
FDA Product Code
HWC
EMDN Code
V0199 Cutting devices, single-use - other
GMDN Term
Orthopaedic intraoperative positioning pin, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
888.3040
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000006446

Other devices from Gebr. Brasseler GmbH & Co. KG

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • 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