Catalog Number

-

Brand Name

DENTEK SLIM BRUSH 32CT IDBR 36

Version/Model Number

10047701002541

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

c19081f3-fd92-49ac-93bc-2600e2eb9475

Public Version Date

October 19, 2022

Public Version Number

1

DI Record Publish Date

October 11, 2022

Package DI Number

10047701002541

Quantity per Package

32

Contains DI Package

00047701002247

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Multiple