Catalog Number

-

Brand Name

Novaplus®

Version/Model Number

V728-B

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KKX

Product Code Name

Drape, surgical

Public Device Record Key

08a969ab-0354-47b5-8093-48debbb273c7

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

August 20, 2016

Package DI Number

20809160025694

Quantity per Package

10

Contains DI Package

10809160025697

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-