Catalog Number

-

Brand Name

D-Lish Orchard Cherry Varnish 200

Version/Model Number

211420

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

f0d0f3b1-aa11-4225-93a8-f3174f6463e8

Public Version Date

October 05, 2022

Public Version Number

6

DI Record Publish Date

September 09, 2016

Package DI Number

20302732114203

Quantity per Package

14

Contains DI Package

10302732114206

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

shipping box