Catalog Number

-

Brand Name

DENTEK EASY BRUSH STD 10CT IDBR 36

Version/Model Number

10047701001131

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

68734a28-e271-4560-b186-783138b099b8

Public Version Date

October 17, 2022

Public Version Number

1

DI Record Publish Date

October 07, 2022

Package DI Number

10047701001131

Quantity per Package

10

Contains DI Package

00047701001134

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Multiple