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FDA product code EZY

Device, Incontinence, Mechanical/Hydraulic

Gastroenterology, UrologyClass 321 CFR 876.5280Implantable
US regulatory classifications
US Product Code (FDA)
EZY
US Risk Class (FDA)
Class 3
US Regulation (CFR)
21 CFR 876.5280
Medical specialty
Gastroenterology, Urology
Device characteristics
GMP exempt
No
Implantable
Yes
Life-sustaining
No
Third party review
Not Eligible
Definition

PMA to be filed by 12/26/00 (65 FR 57731 (9/26/00))

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About this record

Device, Incontinence, Mechanical/Hydraulic 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. This device type includes implantable products.

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.