Catalog Number

-

Brand Name

NovaBright

Version/Model Number

14203-252

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"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LBH

Product Code Name

VARNISH, CAVITY

Public Device Record Key

068b8791-ff64-4dcf-85e4-7407ceb3108c

Public Version Date

June 01, 2020

Public Version Number

1

DI Record Publish Date

May 22, 2020

Package DI Number

00816537021421

Quantity per Package

30

Contains DI Package

00816537021384

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-