Catalog Number

01391MC

Brand Name

SOFTT and UTQ (TMK-UTQ), Multi-Cam

Version/Model Number

01391MC

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OHO

Product Code Name

First Aid Kit Without Drug

Public Device Record Key

ac8662b2-c32b-46f7-a620-da9126d8eb11

Public Version Date

June 01, 2020

Public Version Number

1

DI Record Publish Date

May 22, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-