Catalog Number

-

Brand Name

n.a.

Version/Model Number

21-95-350

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 23, 2022

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

-

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

a126e6df-0faf-48c1-a945-0197bf4014ba

Public Version Date

June 24, 2022

Public Version Number

2

DI Record Publish Date

February 12, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-