Catalog Number

-

Brand Name

HOMEDICS

Version/Model Number

HP-G42AJ

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

IME

Product Code Name

Pack, Hot Or Cold, Reusable

Public Device Record Key

bdadf63f-d8a3-46ed-8712-3421112a7e94

Public Version Date

September 08, 2020

Public Version Number

1

DI Record Publish Date

August 31, 2020

Package DI Number

10031262100204

Quantity per Package

4

Contains DI Package

00031262100207

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case