Catalog Number

FP-OVER2

Brand Name

CARDINAL HEALTH

Version/Model Number

FP-OVER2

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

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

a9c5ae9d-65c3-4311-813f-4de959c318aa

Public Version Date

October 28, 2020

Public Version Number

2

DI Record Publish Date

May 17, 2019

Package DI Number

50885380035980

Quantity per Package

12

Contains DI Package

00885380035985

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE