Catalog Number

-

Brand Name

TopCare

Version/Model Number

TJH

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

ed5ff858-996e-4faa-af1d-bde51cefe106

Public Version Date

July 02, 2020

Public Version Number

1

DI Record Publish Date

June 24, 2020

Package DI Number

10036800400174

Quantity per Package

72

Contains DI Package

00036800400177

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case