Catalog Number

-

Brand Name

Midas Rex Legend

Version/Model Number

10BA80DC

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"

Yes

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

K020069

Product Code

HBB

Product Code Name

MOTOR, DRILL, PNEUMATIC

Public Device Record Key

cfdb13fe-52b3-4a24-94fc-11eea2534cad

Public Version Date

March 02, 2020

Public Version Number

1

DI Record Publish Date

February 22, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-