Catalog Number

-

Brand Name

Core Values

Version/Model Number

3B9

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

0fabf6d8-190e-4da7-8d29-60d1aa0545ef

Public Version Date

December 09, 2020

Public Version Number

1

DI Record Publish Date

December 01, 2020

Package DI Number

00071031773287

Quantity per Package

48

Contains DI Package

00651080396066

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Display