Catalog Number

-

Brand Name

Arctic Flex

Version/Model Number

RHB1055

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)

Yes

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

1408680c-a141-4b55-8690-160fc2a5483f

Public Version Date

November 10, 2021

Public Version Number

1

DI Record Publish Date

November 02, 2021

Package DI Number

10810041987904

Quantity per Package

12

Contains DI Package

00810041987907

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case