Catalog Number

-

Brand Name

TopCare health

Version/Model Number

036800485693

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OMW

Product Code Name

Adhesive Backed Thermal Skin Patches

Public Device Record Key

7626c417-1521-445f-95fb-69701bc02e64

Public Version Date

March 17, 2021

Public Version Number

1

DI Record Publish Date

March 09, 2021

Package DI Number

10036800485690

Quantity per Package

24

Contains DI Package

00036800485693

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box