Catalog Number

600431

Brand Name

Bard® Pezzer-Malecot Stylet

Version/Model Number

600431

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

KOB

Product Code Name

CATHETER, SUPRAPUBIC (AND ACCESSORIES)

Public Device Record Key

b6674bcb-d7ef-4849-8820-51546a0e0716

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

August 06, 2016

Package DI Number

10801741030397

Quantity per Package

5

Contains DI Package

00801741030390

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA