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Midas Rex®

FDA UDI

Class II (US FDA UDI)

by Medtronic Xomed, Inc.

Identity

Trade Name
Midas Rex® FDA UDI
Generic Name
Surgical power tool system control unit, pneumatic FDA UDI
Device Name
ACCY EA201 IPC FOOT CTRL Y-SPLITTER ROHS FDA UDI
Model / Reference
EA201 FDA UDI
Description
ACCY EA201 IPC FOOT CTRL Y-SPLITTER ROHS FDA UDI

Identifiers

Primary DI / UDI-DI
00643169931442 FDA UDI
510(k) Number
K170312 FDA UDI
FDA Product Code
HBE FDA UDI
GMDN Term
Surgical power tool system control unit, pneumatic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4310 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

Category: Surgical power tool system control unit, pneumatic

Midas Rex® by Medtronic Xomed, Inc. — 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

K170312 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medtronic Xomed, Inc.

Sources (1)

  • FDA UDI 89d9f8d1-a59b-4ae6-9deb-b4a84be5ef22 36 fields · synced May 31, 2026