Catalog Number

-

Brand Name

SAM® Junctional Tourniquet

Version/Model Number

JT401-EN

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K131561,K131561,K131561

Product Code

DXC

Product Code Name

Clamp, Vascular

Public Device Record Key

045bef91-4c84-49ca-b638-f9331c030fca

Public Version Date

July 28, 2021

Public Version Number

3

DI Record Publish Date

September 25, 2019

Package DI Number

10822045000367

Quantity per Package

6

Contains DI Package

00822045000360

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case