Catalog Number

-

Brand Name

Disposable Silicone Foley Catheter Two-way 8Fr

Version/Model Number

020-FX-020831

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K130908,K130908,K130908

Product Code

EZL

Product Code Name

Catheter, Retention Type, Balloon

Public Device Record Key

7903ebb9-43f9-41c7-8169-9e0a57a12b71

Public Version Date

December 04, 2020

Public Version Number

9

DI Record Publish Date

September 20, 2016

Package DI Number

26938634494750

Quantity per Package

200

Contains DI Package

16938634494753

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-