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Midas Rex Legend PC100

by Medtronic Powered Surgical Solutions

Ref PC100

Midas Rex Legend PC100 is a device classified as Class I in the EU and Class II in the US made by Medtronic Powered Surgical Solutions, registered in EUDAMED on 25 Sep 2026 (Basic UDI-DI 0763000B00001587J), cleared under FDA 510(k) K163182 on 23 Mar 2017 and listed in FDA GUDID since 9 Oct 2021 (UDI-DI 00763000337551), active as of 7 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K163182

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B00001587J Basic UDI-DI 00763000337551UDI-DIDate25 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00763000337551 UDI-DI Date9 Oct 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK163182 Date23 Mar 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0763000B00001587J registered 25 Sep 2026 Active
  • FDA 510(k) K163182 decided 23 Mar 2017 Active
  • FDA GUDID UDI-DI 00763000337551 listed 9 Oct 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K163182
  2. Listed FDA GUDID 00763000337551
  3. Registered EUDAMED 0763000B00001587J

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Midas Rex Legend
Generic name
Surgical power tool system control unit, pneumatic
Model / reference
PC100
Primary DI / UDI-DI
00763000337551
Basic UDI-DI
0763000B00001587J
510(k) Number
FDA product code
HBB
EMDN code
S010499 Sterilisation containers - other
GMDN term
Surgical power tool system control unit, pneumatic
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.4370
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
High-level Disinfectant

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 00763000337551: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class I 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: Surgical power tool system control unit, pneumatic

Cleared under the same submission (K163182)

and 8 more cleared under K163182

Similar devices in this category

Other devices filed under CONTAINERS FOR STERILISATION.

Other devices from Medtronic Powered Surgical Solutions

See all devices from Medtronic Powered Surgical Solutions →

Properties

  • Sterilise before use NoEUDAMEDYesGUDID
  • Prescription use
  • Serial number
Other properties (22, all answered No)