Catalog Number

-

Brand Name

SmearOFF 16oz Bottle

Version/Model Number

317111

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KJJ

Product Code Name

Cleanser, Root Canal

Public Device Record Key

45eb44b6-f8a1-4150-96eb-5a87df441529

Public Version Date

February 08, 2021

Public Version Number

1

DI Record Publish Date

January 29, 2021

Package DI Number

20818207020622

Quantity per Package

8

Contains DI Package

10818207020625

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-