Catalog Number

-

Brand Name

McKesson

Version/Model Number

63-4418

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GAX

Product Code Name

Tourniquet, Nonpneumatic

Public Device Record Key

b679541a-1126-4e80-a1d3-08ffd8ee8230

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

May 28, 2020

Package DI Number

20612479168774

Quantity per Package

12

Contains DI Package

10612479168944

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box