Catalog Number

-

Brand Name

D-Lish Varnish - Green Apple

Version/Model Number

295732

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

K080814,K080814

Product Code

LBH

Product Code Name

Varnish, Cavity

Public Device Record Key

4f8e3fa0-d4a5-4c17-8468-86763075c8e4

Public Version Date

October 05, 2022

Public Version Number

6

DI Record Publish Date

July 17, 2017

Package DI Number

20302732957329

Quantity per Package

56

Contains DI Package

10302732957322

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-