Catalog Number

-

Brand Name

andorate® Single Use Tourniquet

Version/Model Number

GAR022

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

9e146bab-c028-4618-9aa4-26635a0deea0

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

March 25, 2022

Package DI Number

24897106953671

Quantity per Package

20

Contains DI Package

14897106953674

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton