Catalog Number

-

Brand Name

Cystosure

Version/Model Number

10-400

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

-

Product Code

EZL

Product Code Name

Catheter, Retention Type, Balloon

Public Device Record Key

4e3f071c-330a-4b3b-ac4e-3cad6dad2b75

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

May 28, 2019

Package DI Number

10866403000217

Quantity per Package

5

Contains DI Package

00866403000210

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Box