Catalog Number

-

Brand Name

Thera Med

Version/Model Number

HP1215

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

-

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

IRT

Product Code Name

Pad, Heating, Powered

Public Device Record Key

d405bac5-f7ff-4351-b30f-da2270148471

Public Version Date

July 07, 2020

Public Version Number

3

DI Record Publish Date

December 27, 2016

Package DI Number

30092237614632

Quantity per Package

12

Contains DI Package

00092237614631

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-