Catalog Number

-

Brand Name

CURE ULTRA MALE CATHETER

Version/Model Number

ULTRA M8

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

K080881,K080881,K080881

Product Code

KOD

Product Code Name

Catheter, Urological

Public Device Record Key

27fd2c95-27ef-4be1-b25c-7517ceb9fe22

Public Version Date

October 31, 2022

Public Version Number

5

DI Record Publish Date

April 07, 2017

Package DI Number

20815947021032

Quantity per Package

10

Contains DI Package

10815947021035

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case