Catalog Number

FP-POLE

Brand Name

CARDINAL HEALTH

Version/Model Number

FP-POLE

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

CCX

Product Code Name

SUPPORT, PATIENT POSITION

Public Device Record Key

c95a796e-faf3-418a-a8ce-686df2689710

Public Version Date

October 28, 2020

Public Version Number

4

DI Record Publish Date

August 28, 2018

Package DI Number

50885380162167

Quantity per Package

36

Contains DI Package

10885380162169

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE