Catalog Number

166818

Brand Name

Bardex® All-Silicone Foley Catheter

Version/Model Number

166818

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

GBM

Product Code Name

CATHETER, URETHRAL

Public Device Record Key

1ef8f17c-5efa-4129-a40f-daae534bceab

Public Version Date

December 04, 2020

Public Version Number

8

DI Record Publish Date

May 31, 2016

Package DI Number

10801741029810

Quantity per Package

12

Contains DI Package

00801741029813

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA