Catalog Number

-

Brand Name

Midas Rex Legend

Version/Model Number

PA100-A

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

-

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

K163182,K163182

Product Code

HBB

Product Code Name

MOTOR, DRILL, PNEUMATIC

Public Device Record Key

9b8f03dd-346e-4425-95fc-f3ca7991fc14

Public Version Date

November 09, 2020

Public Version Number

1

DI Record Publish Date

November 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-