Catalog Number

-

Brand Name

OROCARE MINI TOOTHBRUSH

Version/Model Number

3011000

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

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EFW

Product Code Name

Toothbrush, Manual

Public Device Record Key

fa5c3c0d-7c23-45be-a59e-11957ed2d342

Public Version Date

February 07, 2022

Public Version Number

2

DI Record Publish Date

October 15, 2021

Package DI Number

05030267098989

Quantity per Package

120

Contains DI Package

05030267098071

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-