Catalog Number

-

Brand Name

WellPatch(R) MIGRAINE & HEADACHE Cooling Patch, 4 Count

Version/Model Number

1570

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

IMD

Product Code Name

Pack, Hot Or Cold, Disposable

Public Device Record Key

e46f20cb-ce14-4f35-bbae-33897c0b86e4

Public Version Date

February 17, 2020

Public Version Number

1

DI Record Publish Date

February 07, 2020

Package DI Number

00310742915709

Quantity per Package

6

Contains DI Package

00310742015713

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case