FDA product code MNG

External Urethral Occluder, Urinary Incontinence-Control, Female

Gastroenterology, Urology·Class 1·21 CFR 876.5160
US regulatory classifications
US Product Code (FDA)
MNG
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US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 876.5160
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Medical specialty
Gastroenterology, Urology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

Intended to prevent or decrease episodes of urine leakage in women with stress incontinence. Occluder is applied to urinary meatus through suction or tape, which creates a barrier for urine leakage. Occluding device such as a cap, suction cup, or foam pad. May include adhesive gel or ointment.

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About this record

External Urethral Occluder, Urinary Incontinence-Control, Female 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.