Catalog Number

SMA44CPADD

Brand Name

CARDINAL HEALTH

Version/Model Number

SMA44CPADD

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OHM

Product Code Name

Cesarean section tray

Public Device Record Key

698d4553-f4b5-4237-9d9e-c0bde05d027e

Public Version Date

October 22, 2018

Public Version Number

4

DI Record Publish Date

August 16, 2016

Package DI Number

50885425994340

Quantity per Package

1

Contains DI Package

10885425994342

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE