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MR8-23TD3010

by Medtronic Ablation Frontiers, LLC

Ref MR8-23TD3010

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 24 Oct 2026

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 Number0763000B000139487 Basic UDI-DI 00763000865641UDI-DIDate28 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000865641 UDI-DI Date1 Dec 2023ListedStatusListed 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 24 Oct 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  • Withdrawn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
MR8
Generic Name
Orthopaedic bur, single-use
Device Name
MR8 Twist Drill Tool
Model / Reference
MR8-23TD3010
Primary DI / UDI-DI
00763000865641
Basic UDI-DI
0763000B000139487
510(k) Number
FDA Product Code
HBC, HSZ, HBB, HBE, ERL
EMDN Code
Z12100985 Instruments for motorised neurosurgery systems - consumables
GMDN Term
Orthopaedic bur, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
882.4360, 878.4820, 882.4370, 882.4310, 874.4250
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Orthopaedic bur, single-use

Cleared under the same submission (K183515)

Show all (12)

Other devices from Medtronic Ablation Frontiers, LLC

Properties

  • Sterile
  • Single Use
  • Lot / Batch Number

Other properties (21)

  • 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
  • Prescription Use: 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