Catalog Number

135105

Brand Name

Bard® Polyurethane Ureteral Catheters, Open Tip

Version/Model Number

135105

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EYB

Product Code Name

CATHETER, URETERAL, GASTRO-UROLOGY

Public Device Record Key

86f7c607-06e7-443a-a0eb-7922e7028421

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

July 23, 2016

Package DI Number

10801741108676

Quantity per Package

10

Contains DI Package

00801741108679

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA