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Codman® 261247

by Integra LifeSciences Production Corporation

Ref 26-1247

Codman® 261247 (26-1247) is a device classified as Class IIa in the EU and Class II in the US made by Integra LifeSciences Production Corporation, registered in EUDAMED on 16 Sep 2026 (Basic UDI-DI B-10381780513667) and listed in FDA GUDID since 1 Apr 2020 (UDI-DI 10381780513667), active as of 25 Oct 2026.

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

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10381780513667 Basic UDI-DI 10381780513667UDI-DIDate16 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780513667 UDI-DI Date1 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-10381780513667 registered 16 Sep 2026 Active
  • FDA GUDID UDI-DI 10381780513667 listed 1 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10381780513667
  2. Registered EUDAMED B-10381780513667

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Codman®
Generic name
Manual cranial rotary handpiece, single-use
Device name
Cranial Access
Model / Ref / Catalog
26-1247, 261247
Primary DI / UDI-DI
10381780513667
Basic UDI-DI
B-10381780513667
FDA product code
HBE
EMDN code
P091304 Cranial perforators, single-use
GMDN term
Manual cranial rotary handpiece, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4310
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
26-1247
GUDID
261247
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Manual cranial rotary handpiece, single-use

Similar devices in this category

Other devices filed under CRANIAL PERFORATORS, SINGLE-USE.

Other devices from Integra LifeSciences Production Corporation

See all devices from Integra LifeSciences Production Corporation →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)