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Stealth Midas™

FDA UDI

Class II (US FDA UDI)

by Medtronic Powered Surgical Solutions

Identity

Trade Name
Stealth Midas™ FDA UDI
Generic Name
Bone/joint surgical power tool motor, electric FDA UDI
Device Name
MOTOR EM200N STEALTH-MIDAS STYLUS FDA UDI
Model / Reference
EM200N FDA UDI
Description
MOTOR EM200N STEALTH-MIDAS STYLUS FDA UDI

Identifiers

Primary DI / UDI-DI
00643169595163 FDA UDI
510(k) Number
K160713 FDA UDI
FDA Product Code
OLO FDA UDI
GMDN Term
Bone/joint surgical power tool motor, electric FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4560 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: Bone/joint surgical power tool motor, electric

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

Similar devices

Also classified as Bone/joint surgical power tool motor, electric.

Cleared under the same submission

K160713 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 3ebf05f9-f8fb-4cb7-a27f-5cda52c97fff 35 fields · synced Jun 9, 2026