Catalog Number

-

Brand Name

Hysynal

Version/Model Number

10264

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"

-

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

55b6dc63-b002-444d-946e-ea22abb80067

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

April 08, 2019

Package DI Number

30087453102643

Quantity per Package

10

Contains DI Package

10087453102649

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton