Catalog Number

98302-0001-93

Brand Name

Clever Choice

Version/Model Number

Comfort Heat SDI-HPR

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

797bc27f-411c-45d1-a3f6-2b445e0c3e2e

Public Version Date

July 07, 2020

Public Version Number

2

DI Record Publish Date

April 02, 2019

Package DI Number

10898302001934

Quantity per Package

12

Contains DI Package

00898302001937

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-