MIDAS REX MR8 - TOOL MR8-T12MH45D MR8 12CM TL MH D 4.5MM - MEDTRONIC POWERED SURGICAL SOLUTIONS

Duns Number:098308849

Device Description: TOOL MR8-T12MH45D MR8 12CM TL MH D 4.5MM

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More Product Details

Catalog Number

-

Brand Name

MIDAS REX MR8

Version/Model Number

MR8-T12MH45D

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K183515

Product Code Details

Product Code

HBE

Product Code Name

DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Device Record Status

Public Device Record Key

76ed73f1-3c20-4edb-ab34-742e7c43ca20

Public Version Date

January 03, 2022

Public Version Number

1

DI Record Publish Date

December 24, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDTRONIC POWERED SURGICAL SOLUTIONS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 450
2 A medical device with a moderate to high risk that requires special controls. 3534