Catalog Number

-

Brand Name

Dr. Talbot's

Version/Model Number

80100

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

-

Product Code

JEQ

Product Code Name

Toothbrush, Powered

Public Device Record Key

2372be92-4672-44ae-8bc9-17947de62335

Public Version Date

July 23, 2020

Public Version Number

1

DI Record Publish Date

July 15, 2020

Package DI Number

20370797801000

Quantity per Package

6

Contains DI Package

00370797801006

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-