FDA product code OOA

Hemorrhoid Prevention Pressure Wedge

Obstetrics/Gynecology·Class 2·21 CFR 884.5200
US regulatory classifications
US Product Code (FDA)
OOA
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 884.5200
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Medical specialty
Obstetrics/Gynecology
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

Provides a counter-pressure to the anus during vaginal delivery. Intended to prevent the occurrence of and/or stop the progression of hemorrhoids associated with vaginal delivery.

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About this record

Hemorrhoid Prevention Pressure Wedge is a medical device type in the Obstetrics/Gynecology 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.