Catalog Number

0170SI24

Brand Name

Bardex® Lubri-Sil® I.C. All-Silicone Foley Catheter

Version/Model Number

0170SI24

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

EZL

Product Code Name

CATHETER, RETENTION TYPE, BALLOON

Public Device Record Key

b018a2b7-141f-4261-b4fa-769626d4c400

Public Version Date

December 04, 2020

Public Version Number

5

DI Record Publish Date

March 19, 2016

Package DI Number

10801741124102

Quantity per Package

12

Contains DI Package

00801741124105

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CA