Catalog Number

-

Brand Name

McKesson

Version/Model Number

MCKFOL

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 20, 2018

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EYJ

Product Code Name

Holder, Ureteral Catheter

Public Device Record Key

382735f2-8b44-4724-84a7-d0568ef7033f

Public Version Date

July 22, 2019

Public Version Number

6

DI Record Publish Date

February 13, 2018

Package DI Number

20612479228713

Quantity per Package

10

Contains DI Package

10612479228709

Package Discontinue Date

September 20, 2018

Package Status

Not in Commercial Distribution

Package Type

Box