Catalog Number

-

Brand Name

Freshmint

Version/Model Number

FLSPK

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

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

3efb7420-97aa-471f-9b96-fb552494b2d0

Public Version Date

August 21, 2020

Public Version Number

1

DI Record Publish Date

August 13, 2020

Package DI Number

00085317008635

Quantity per Package

4

Contains DI Package

00085317008642

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case