Catalog Number

SPP99CS1AA

Brand Name

CARDINAL HEALTH

Version/Model Number

SPP99CS1AA

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

ff70fd03-1bbe-463b-b53b-27a1a3da9052

Public Version Date

May 24, 2022

Public Version Number

5

DI Record Publish Date

August 03, 2016

Package DI Number

50885425482717

Quantity per Package

2

Contains DI Package

10885425482719

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE