Catalog Number

PGCGLBCD5

Brand Name

CARDINAL HEALTH

Version/Model Number

PGCGLBCD5

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

OHD

Product Code Name

Gynecological laparoscopic kit

Public Device Record Key

2fa14fd6-0446-4ab2-8d87-d82fea855948

Public Version Date

November 19, 2019

Public Version Number

1

DI Record Publish Date

November 11, 2019

Package DI Number

50888439626313

Quantity per Package

2

Contains DI Package

10888439626315

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE