Catalog Number

137904

Brand Name

Bard® Polyurethane Ureteral Catheters, Spiral Tip

Version/Model Number

137904

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

KOE

Product Code Name

DILATOR, URETHRAL

Public Device Record Key

d002444b-3525-4405-a10c-83f3a6c4b934

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

July 23, 2016

Package DI Number

10801741108706

Quantity per Package

10

Contains DI Package

00801741108709

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA