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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
Burring power tool attachment FDA UDI
Device Name
ATT MR8 MR8-AS15 15CM STRAIGHT 2.4MM FDA UDI
Model / Reference
MR8-AS15 FDA UDI
Description
ATT MR8 MR8-AS15 15CM STRAIGHT 2.4MM FDA UDI

Identifiers

Primary DI / UDI-DI
00643169912250 FDA UDI
510(k) Number
K183515 FDA UDI
FDA Product Code
HBE FDA UDI
GMDN Term
Burring power tool attachment 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Burring power tool attachment

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 Burring power tool attachment.

Cleared under the same submission

K183515 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 db3695a2-1b03-433a-b0f2-5520e0e5587f 35 fields · synced Jun 9, 2026