Catalog Number

-

Brand Name

n.a.

Version/Model Number

24-00-100

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KCY

Product Code Name

Tourniquet, Pneumatic

Public Device Record Key

81a12f35-7d9a-48d1-8706-5bea00fb0088

Public Version Date

June 11, 2020

Public Version Number

1

DI Record Publish Date

June 03, 2020

Package DI Number

14250105620501

Quantity per Package

40

Contains DI Package

04250105620504

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-