Catalog Number

TK18L100

Brand Name

Centurion

Version/Model Number

TK18L100

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

bf7e54f2-6a4a-4b40-a482-eedaa311176a

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

January 02, 2022

Package DI Number

50653160022426

Quantity per Package

100

Contains DI Package

00653160022421

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE