Catalog Number

STLFTK9

Brand Name

Centurion

Version/Model Number

STLFTK9

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

GAX

Product Code Name

TOURNIQUET, NONPNEUMATIC

Public Device Record Key

3e0dbfe8-bc0d-418b-a0b3-af392a23a17f

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

January 02, 2022

Package DI Number

10653160096177

Quantity per Package

50

Contains DI Package

00653160096170

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE