Catalog Number

SMA14CSUR2

Brand Name

CARDINAL HEALTH

Version/Model Number

SMA14CSUR2

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

a4fbc925-47df-4337-8ecd-cba43800a8e2

Public Version Date

January 04, 2022

Public Version Number

1

DI Record Publish Date

December 27, 2021

Package DI Number

50195594491114

Quantity per Package

2

Contains DI Package

10195594491116

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE