Catalog Number

-

Brand Name

Silicone 2-way Foley Balloon Catheter (Integrated Balloon)

Version/Model Number

4822-0516

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K980919,K980919

Product Code

EZL

Product Code Name

Catheter, Retention Type, Balloon

Public Device Record Key

64aac061-86c0-451d-ac02-2af74aaccff5

Public Version Date

December 04, 2020

Public Version Number

9

DI Record Publish Date

March 11, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-