Catalog Number

PB23HSSAT

Brand Name

CARDINAL HEALTH

Version/Model Number

PB23HSSAT

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

OJF

Product Code Name

Hysterectomy kit

Public Device Record Key

25b3b752-a487-487b-89de-05cc38c1e164

Public Version Date

July 23, 2018

Public Version Number

2

DI Record Publish Date

April 26, 2018

Package DI Number

50887488944041

Quantity per Package

2

Contains DI Package

10887488944043

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE