Catalog Number

-

Brand Name

ThermaCare HeatWraps

Version/Model Number

ThermaCare HeatWraps - Lower Back & Hip

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 30, 2020

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

9e7aafc9-4ed1-4d6b-b124-14a086c2b102

Public Version Date

December 17, 2020

Public Version Number

2

DI Record Publish Date

May 29, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-