Catalog Number

-

Brand Name

Hygenic

Version/Model Number

02002

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

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

68e037b4-a9a7-42e0-a6b3-865c93232e17

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

April 08, 2019

Package DI Number

20087453020025

Quantity per Package

4

Contains DI Package

10087453020028

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton