Catalog Number

-

Brand Name

DENTEK EASY BRUSH 16CT WIDE 36

Version/Model Number

30047701002583

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

Yes

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

EFW

Product Code Name

Toothbrush, Manual

Public Device Record Key

c1cff0be-cdbf-4a29-a7a0-559c30045b4d

Public Version Date

October 17, 2022

Public Version Number

1

DI Record Publish Date

October 07, 2022

Package DI Number

30047701002583

Quantity per Package

16

Contains DI Package

00047701002582

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Multiple