Catalog Number

-

Brand Name

NOVAPLUS

Version/Model Number

VTQK312

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)

-

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

f4a20db5-905b-4533-a53c-fef82a3c4fba

Public Version Date

August 03, 2022

Public Version Number

1

DI Record Publish Date

July 26, 2022

Package DI Number

10840216100777

Quantity per Package

1000

Contains DI Package

00840216100770

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE