Catalog Number

PB1DAHUNL

Brand Name

CARDINAL HEALTH

Version/Model Number

PB1DAHUNL

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

OJF

Product Code Name

Hysterectomy kit

Public Device Record Key

6db3b46b-3371-4712-aa0d-24e5ea9c8523

Public Version Date

April 30, 2021

Public Version Number

1

DI Record Publish Date

April 22, 2021

Package DI Number

50888439974001

Quantity per Package

2

Contains DI Package

10888439974003

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE