Catalog Number

910300

Brand Name

C3

Version/Model Number

Male Continence Device

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

December 31, 2025

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"

-

For Single-Use

-

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

FHA

Product Code Name

Clamp, Penile

Public Device Record Key

632763eb-8105-46b0-96bb-86a675c400ca

Public Version Date

July 07, 2020

Public Version Number

2

DI Record Publish Date

August 27, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-