DEVICE: Midas Rex MR8 (00643169912151)
Device Identifier (DI) Information
Midas Rex MR8
EM800N
In Commercial Distribution
MEDTRONIC POWERED SURGICAL SOLUTIONS
EM800N
In Commercial Distribution
MEDTRONIC POWERED SURGICAL SOLUTIONS
MOTOR EM800N MR8 ELECTRIC NAVIGATED S8
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
33541 | Bone/joint surgical power tool motor, electric |
A hand-held, electrically-powered component of a surgical power tool assembly designed to convert electrical energy into a non-dedicated mechanical energy to perform a variety of surgical procedures such as drilling or sawing of bones and tough tissues; it is not dedicated to dental procedures. It is designed to accept a motorless handpiece component/attachment (not included) and it is not intended to directly accept an endpiece (e.g., drill bit, saw blade). It may be a micro or macro style device, be cannulated to permit use of a guidewire, include a rechargeable battery, and might be operated with a hand- or foot-switch. This is a reusable device.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
OLO | Orthopedic stereotaxic instrument |
HAW | Neurological stereotaxic Instrument |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K183644 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
8955ba1f-71a1-4d2e-ba47-d93e572fd7c9
September 19, 2024
3
August 08, 2019
September 19, 2024
3
August 08, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)633-8766
Corporate.UDI@medtronic.com
Corporate.UDI@medtronic.com