Catalog Number

-

Brand Name

Technologist Choice

Version/Model Number

TOR-23BT

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)

-

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

c2bbc639-0e8f-4af5-85bf-73f87886df02

Public Version Date

October 13, 2022

Public Version Number

1

DI Record Publish Date

October 05, 2022

Package DI Number

00754013509974

Quantity per Package

20

Contains DI Package

00754013509981

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case