Catalog Number

31802

Brand Name

Arctic Sun® Temperature Management System, ArcticGel™ Pads

Version/Model Number

31802

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

DWJ

Product Code Name

System, thermal regulating

Public Device Record Key

eca1e55f-1b8b-46fc-a7e2-6b50475bd852

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 11, 2016

Package DI Number

10801741132138

Quantity per Package

1

Contains DI Package

00801741132131

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA