Catalog Number

-

Brand Name

ESMARK 3X12 ST 20/CS

Version/Model Number

18320000

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

e30f911d-b5ca-4317-a6e3-e0ad7357e3fd

Public Version Date

September 09, 2020

Public Version Number

1

DI Record Publish Date

September 01, 2020

Package DI Number

40612553014540

Quantity per Package

20

Contains DI Package

10612553014549

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-