Devices

Genesis Malleable Penile Prosthesis

Model / Serial
4336612, 4364589 , 4413811, 4413812, 4336613, 4413810.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide - US Nationwide Distribution in the states of FL, NY, TX and the country of FRANCE
Product Description
Genesis Malleable Penile Prosthesis, 9.5 mm, Catalog /Item Number 91-9509SC/519250. || Product Usage: || The Coloplast Genesis Penile prosthesis is a flexible silicone elastomer device designed to be implanted into the penis for the management of erectile dysfunction.
Manufacturer
Coloplast Manufacturing US, LLC
1 Event
- Recall of Genesis Malleable Penile Prosthesis

Manufacturer

Coloplast Manufacturing US, LLC

Manufacturer Address
Coloplast Manufacturing US, LLC, 1601 W River Rd, Minneapolis MN 55411-3431
Manufacturer Parent Company (2017)
Coloplast A/S
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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