Catalog Number

-

Brand Name

CareOne

Version/Model Number

SUK

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)

-

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

b98f3c3e-bb20-4b72-a649-eda8cce55913

Public Version Date

January 08, 2021

Public Version Number

2

DI Record Publish Date

August 27, 2020

Package DI Number

10041520137859

Quantity per Package

24

Contains DI Package

00041520137852

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case