Catalog Number

-

Brand Name

NOVAPLUS

Version/Model Number

VTQK305

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

8fbe0b27-587a-4654-a823-d5b977e13a4d

Public Version Date

August 03, 2022

Public Version Number

1

DI Record Publish Date

July 26, 2022

Package DI Number

10840216100708

Quantity per Package

500

Contains DI Package

00840216100701

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE