Catalog Number

-

Brand Name

Equate

Version/Model Number

STT

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

18b88b74-3c3e-4363-b4bf-9cdd7b4e57e8

Public Version Date

August 11, 2021

Public Version Number

1

DI Record Publish Date

August 03, 2021

Package DI Number

10681131449011

Quantity per Package

6

Contains DI Package

00681131449014

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner