Catalog Number

-

Brand Name

Listerine

Version/Model Number

00312547235952

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K143155

Product Code

LBH

Product Code Name

VARNISH, CAVITY

Public Device Record Key

8dbe41d5-d65f-4d6e-871e-ff60423cbc6d

Public Version Date

February 07, 2019

Public Version Number

4

DI Record Publish Date

December 10, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-