Catalog Number

-

Brand Name

WONDERFUL 5% NAF VARNISH CLEAR STRAWBERRY SINGLES

Version/Model Number

295989

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

a4a6cb13-9589-4d35-b023-72d1f2938eab

Public Version Date

October 05, 2022

Public Version Number

4

DI Record Publish Date

September 04, 2018

Package DI Number

20302732959897

Quantity per Package

10

Contains DI Package

10302732959890

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-