Catalog Number

-

Brand Name

2-lumen Catheter for UPP, 9F

Version/Model Number

9021P5892

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 09, 2020

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

FEN

Product Code Name

DEVICE, CYSTOMETRIC, HYDRAULIC

Public Device Record Key

84050928-44f5-44cd-954c-c51ac3603e51

Public Version Date

September 10, 2020

Public Version Number

3

DI Record Publish Date

September 21, 2016

Package DI Number

10627825008218

Quantity per Package

10

Contains DI Package

00627825008211

Package Discontinue Date

September 09, 2020

Package Status

Not in Commercial Distribution

Package Type

-