Catalog Number

-

Brand Name

Up&Up

Version/Model Number

3R1

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

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

b58b91fd-b564-421b-bb26-7f24f012e861

Public Version Date

July 07, 2020

Public Version Number

2

DI Record Publish Date

January 21, 2020

Package DI Number

10071031846520

Quantity per Package

36

Contains DI Package

00071031846523

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-