Catalog Number

-

Brand Name

WellPatch(R) HEAT THERAPY PAIN RELIEF PATCH

Version/Model Number

9842

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

457a883b-bce5-4f4e-a91b-c94d9ab45189

Public Version Date

February 17, 2020

Public Version Number

1

DI Record Publish Date

February 07, 2020

Package DI Number

00310742998429

Quantity per Package

120

Contains DI Package

00310742098426

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case