Catalog Number

4000

Brand Name

Toothette Oral Care

Version/Model Number

4000

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"

Yes

For Single-Use

Yes

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

-

Product Code

BRW

Product Code Name

PROTECTOR, DENTAL

Public Device Record Key

959d46ce-8f48-42cd-894d-b185e7083744

Public Version Date

September 24, 2018

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

50618029810323

Quantity per Package

144

Contains DI Package

00618029810328

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case