Catalog Number

-

Brand Name

CURE ULTRA MALE CATHETER

Version/Model Number

Ultra M10C

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

K072539,K072539,K072539

Product Code

EZD

Product Code Name

Catheter, Straight

Public Device Record Key

70d5bf7a-8e44-49fc-b295-2f93192e03b4

Public Version Date

October 31, 2022

Public Version Number

3

DI Record Publish Date

February 14, 2022

Package DI Number

10815947021097

Quantity per Package

10

Contains DI Package

00815947021090

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box