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Elan 4 GP337R

by Aesculap, Inc.

Ref GP337R

Active European Union. Also listed in GUDID (US), not in commercial distribution.

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number40392390000014572P Basic UDI-DI 04046964560279UDI-DIDate18 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04046964560279 UDI-DI Date30 Apr 2019ListedStatusListed GUDID: not 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  • Withdrawn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
Elan 4
Generic Name
Orthopaedic bur, reusable
Device Name
ELAN 4 rotating instrument (RU)
Model / Ref / Catalog
GP337R
Primary DI / UDI-DI
04046964560279
Basic UDI-DI
40392390000014572P
FDA Product Code
HBE
EMDN Code
Z12100980 Instruments for motorised neurosurgery systems - hardware accessories
GMDN Term
Orthopaedic bur, reusable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
882.4310
EU market of registration
Germany
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Other devices from Aesculap, Inc.

See all devices from Aesculap, Inc. →

Properties

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

Other properties (20)

  • 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
  • Manufacturing Date: No