Catalog Number

SWAT-T ORG-CA

Brand Name

SWAT-T Orange Tourniquet, 100/case

Version/Model Number

01

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

7ff06618-5d48-4968-839d-d7705a607ea1

Public Version Date

April 12, 2022

Public Version Number

2

DI Record Publish Date

October 09, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-