Catalog Number

064016

Brand Name

Bardex® Pezzer Model Drain

Version/Model Number

064016

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)

Yes

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

FEW

Product Code Name

Catheter, malecot

Public Device Record Key

b71b6f27-14ce-4fd1-9a55-9be98f127a8a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 10, 2016

Package DI Number

10801741030045

Quantity per Package

6

Contains DI Package

00801741030048

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA