Catalog Number

-

Brand Name

Cystosure

Version/Model Number

10-600

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

-

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

-

FDA Premarket Submission

K172422,K172422,K172422

Product Code

EZL

Product Code Name

Catheter, Retention Type, Balloon

Public Device Record Key

2d8ff963-1d89-4532-ae08-ed73b9d977ba

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

May 28, 2019

Package DI Number

10866403000200

Quantity per Package

5

Contains DI Package

00866403000203

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box