Catalog Number

-

Brand Name

Catheter, Pabd, Single Lumen, Closed Balloon, Silicone, 12Fr

Version/Model Number

CATW1A112B

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)

-

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

1f98df19-d7ff-4312-8191-385c14a88261

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 01, 2017

Package DI Number

30627825010475

Quantity per Package

100

Contains DI Package

20627825010478

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-