Catalog Number

-

Brand Name

Freshmint

Version/Model Number

DENT40

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

EFT

Product Code Name

Cleanser, Denture, Over The Counter

Public Device Record Key

d44a5411-3341-4070-bda4-6e051673d876

Public Version Date

August 19, 2020

Public Version Number

1

DI Record Publish Date

August 11, 2020

Package DI Number

00085317003708

Quantity per Package

24

Contains DI Package

00085317003715

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case