FDA product code QWW

Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction.

Gastroenterology, Urology·Class 2·21 CFR 876.5021
US regulatory classifications
US Product Code (FDA)
QWW
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 876.5021
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Medical specialty
Gastroenterology, Urology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

A non-medicated topical formulation for treatment of erectile dysfunction is a device that is applied on the penis and stimulates the nerve endings by inducing a temperature change, leading to tumescence and erection.

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About this record

Non-Medicated Topical Formulation For Treatment Of Erectile Dysfunction. is a medical device type in the Gastroenterology, Urology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.