Catalog Number

C-PG25I

Brand Name

CARDINAL HEALTH

Version/Model Number

C-PG25I

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"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

FER

Product Code Name

Anoscope and accessories

Public Device Record Key

e889ba8a-0691-4180-9a3c-39b8857f7f67

Public Version Date

June 06, 2019

Public Version Number

1

DI Record Publish Date

May 29, 2019

Package DI Number

50885380052161

Quantity per Package

12

Contains DI Package

10885380052163

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE