Catalog Number

-

Brand Name

Cypress

Version/Model Number

63-34

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)

-

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

4ee20a09-82ae-44a7-a3a5-8f90fd1f7f22

Public Version Date

June 10, 2022

Public Version Number

3

DI Record Publish Date

May 20, 2020

Package DI Number

00815555024094

Quantity per Package

4

Contains DI Package

00815555024087

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case