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Midas Rex Stealth-Midas MR8 PM800N

by Medtronic Powered Surgical Solutions United States EUDAMEDGUDID

Ref PM800N

Product code OLOEMDN Z12100902

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00013417J Basic UDI-DIDate14 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000431020 UDI-DIDate5 Dec 2021ListedStatusIn distribution

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Trade Name
Midas Rex Stealth-Midas MR8
Generic Name
Surgical power tool system control unit, pneumatic
Device Name
MR8 Pneumatic Motor Navigated
Model / Reference
PM800N
Primary DI / UDI-DI
00763000431020, 00763000730543, 00763000728656, 00763000730253, 00763000731410, 00763000728946, 00763000730833
Basic UDI-DI
0763000B00013417J
510(k) Number
FDA Product Code
OLO, HAW
EMDN Code
Z12100902 Drills for neurosurgery
GMDN Term
Surgical power tool system control unit, pneumatic
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
882.4560
Market of Registration
Netherlands
Commercial Distribution
In Commercial Distribution
Sterilization Method
Ethylene Oxide

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Surgical power tool system control unit, pneumatic

Cleared under the same submission (K183644)

Show all (9)

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Properties & raw data

Show properties, registry sources and raw records
  • Reprocessed
  • Prescription Use
  • Serial Number
Other properties (21)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: 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
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (8)

  • FDA UDI 63811f34-a544-4870-b119-588b7739575c 35 fields · synced 24 Oct 2026
  • EUDAMED 00763000730543|0763000B00013417J 61 fields · synced 7 Oct 2026
  • EUDAMED 00763000728656|0763000B00013417J 61 fields · synced 8 Oct 2026
  • EUDAMED 00763000730253|0763000B00013417J 61 fields · synced 8 Oct 2026
  • EUDAMED 00763000731410|0763000B00013417J 61 fields · synced 24 Oct 2026
  • EUDAMED 00763000728946|0763000B00013417J 61 fields · synced 24 Oct 2026
  • EUDAMED 00763000730833|0763000B00013417J 61 fields · synced 24 Oct 2026
  • EUDAMED 00763000431020|0763000B00013417J 61 fields · synced 24 Oct 2026