Catalog Number

0166V16S

Brand Name

Bardex® Silicone Coated Foley Catheter

Version/Model Number

0166V16S

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

KOD

Product Code Name

CATHETER, UROLOGICAL

Public Device Record Key

f5b572bf-c51f-4010-9ed8-50d20f23baa5

Public Version Date

December 04, 2020

Public Version Number

8

DI Record Publish Date

June 10, 2016

Package DI Number

10801741039499

Quantity per Package

12

Contains DI Package

00801741039492

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA