Catalog Number

-

Brand Name

HCS

Version/Model Number

HCS5001

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

ebf54822-5fa9-4dc6-b5ef-4d3867a7a3eb

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

February 28, 2020

Package DI Number

10849027000504

Quantity per Package

4

Contains DI Package

00849027000507

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-