Catalog Number

31801

Brand Name

Arctic Sun® Temperature Management System, ArcticGel™ Pads

Version/Model Number

31801

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Safe

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

b8fbc460-9a06-4282-ba62-8a84cab6fdb3

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 09, 2016

Package DI Number

10801741080125

Quantity per Package

1

Contains DI Package

00801741080128

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA