Catalog Number

-

Brand Name

MIDAS REX MR8

Version/Model Number

MR8-ND13BA40DC

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

HBE

Product Code Name

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

Public Device Record Key

958a71a2-8363-4d57-b003-ebc43c69c739

Public Version Date

April 22, 2022

Public Version Number

1

DI Record Publish Date

April 14, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-