Catalog Number

-

Brand Name

Varnish America 0.4ml Box / 200 White Mint

Version/Model Number

07-0122

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

7512a450-3f7c-4cd7-b9aa-8eeeae6f10d2

Public Version Date

October 05, 2022

Public Version Number

5

DI Record Publish Date

August 31, 2017

Package DI Number

20302730701221

Quantity per Package

12

Contains DI Package

10302730701224

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box