Catalog Number

-

Brand Name

Novaplus®

Version/Model Number

V708-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

1a894982-c261-44e5-a520-dfbac8132790

Public Version Date

June 07, 2019

Public Version Number

4

DI Record Publish Date

August 20, 2016

Package DI Number

50809160001392

Quantity per Package

10

Contains DI Package

10809160001394

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-