Catalog Number

-

Brand Name

TopCare

Version/Model Number

UGN

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

5c574e0d-91ea-44d6-a189-b8d7b241a4ec

Public Version Date

July 02, 2020

Public Version Number

1

DI Record Publish Date

June 24, 2020

Package DI Number

00036800384422

Quantity per Package

144

Contains DI Package

00036800561274

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case