Catalog Number

-

Brand Name

Artic Flex

Version/Model Number

RHB1063BLU

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

cce55486-a209-4a1a-982c-32ffa5181585

Public Version Date

April 01, 2019

Public Version Number

1

DI Record Publish Date

March 24, 2019

Package DI Number

10818323024460

Quantity per Package

20

Contains DI Package

00818323024463

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case