← Back to catalogue

Midas Rex Mr8

FDA UDI

Class II (US FDA UDI)

by Medtronic Powered Surgical Solutions

Identity

Trade Name
MIDAS REX MR8 FDA UDI
Generic Name
Surgical power tool system control unit, pneumatic FDA UDI
Device Name
MOTOR PM800 MR8 PNEUMATIC FDA UDI
Model / Reference
PM800 FDA UDI
Description
MOTOR PM800 MR8 PNEUMATIC FDA UDI

Identifiers

Primary DI / UDI-DI
00763000431013 FDA UDI
510(k) Number
K183515 FDA UDI
K183644 FDA UDI
FDA Product Code
HBB FDA UDI
ERL FDA UDI
GMDN Term
Surgical power tool system control unit, pneumatic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4370 FDA UDI
874.4250 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Surgical power tool system control unit, pneumatic

Midas Rex Mr8 by Medtronic Powered Surgical Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical power tool system control unit, pneumatic.

Cleared under the same submission

K183515 also covers:

K183644 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Medtronic Powered Surgical Solutions

Sources (1)

  • FDA UDI 9df46a4c-d1b8-4632-ae09-299000e3672c 35 fields · synced Jun 9, 2026