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Midas Rex®

FDA UDI

Class II (US FDA UDI)

by Medtronic Powered Surgical Solutions

Identity

Trade Name
Midas Rex® FDA UDI
Generic Name
Surgical power tool system control unit, pneumatic FDA UDI
Device Name
ACCY PC101 LEGEND PNEU CONTROL UNIT FDA UDI
Model / Reference
PC101 FDA UDI
Description
ACCY PC101 LEGEND PNEU CONTROL UNIT FDA UDI

Identifiers

Primary DI / UDI-DI
10885074107759 FDA UDI
510(k) Number
K020069 FDA UDI
FDA Product Code
HBB 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
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
Liquid Chemical FDA UDI

Category: Surgical power tool system control unit, pneumatic

Midas Rex® 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

K020069 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic Powered Surgical Solutions

Sources (1)

  • FDA UDI 6de108da-d7fa-44d1-ad0f-9d6cdb23f014 35 fields · synced Jun 9, 2026