Catalog Number

-

Brand Name

NA

Version/Model Number

ST-S

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

GAX

Product Code Name

Tourniquet, Nonpneumatic

Public Device Record Key

b927d377-ce16-478b-9428-1554e4d17f04

Public Version Date

June 10, 2022

Public Version Number

4

DI Record Publish Date

April 19, 2017

Package DI Number

10858778006826

Quantity per Package

50

Contains DI Package

00858778006829

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton