Catalog Number

-

Brand Name

DENTEK 3 IN 1 16CT FLOSS PICK 36

Version/Model Number

10047701111847

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

JES

Product Code Name

Floss, Dental

Public Device Record Key

96cf478e-44fa-49d6-aacb-a7d2d68e0dfc

Public Version Date

October 28, 2022

Public Version Number

1

DI Record Publish Date

October 20, 2022

Package DI Number

10047701111847

Quantity per Package

16

Contains DI Package

00047701111840

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Multiple