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Midas Rex MR8 MR8-SD12BA40

by Medtronic Powered Surgical Solutions EUDAMEDGUDID

Active European Union

Ref MR8-SD12BA40

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00013978D Basic UDI-DIDate10 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000513801 UDI-DIDate14 Apr 2022ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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 on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Midas Rex MR8
Generic Name
Orthopaedic bur, single-use
Device Name
MR8 Clearview Spine Tool
Model / Reference
MR8-SD12BA40
Primary DI / UDI-DI
00763000513801
Basic UDI-DI
0763000B00013978D
510(k) Number
FDA Product Code
HSZ, HBE
EMDN Code
Z12100985 Instruments for motorised neurosurgery systems - consumables
GMDN Term
Orthopaedic bur, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
878.4820, 882.4310
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 I

Related devices

Category: Orthopaedic bur, single-use

Cleared under the same submission (K183515)

Show all (12)

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (20)

  • 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