FDA product code OMP

Negative Pressure Wound Therapy Powered Suction Pump

General, Plastic Surgery·Class 2·21 CFR 878.4780
US regulatory classifications
US Product Code (FDA)
OMP
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 878.4780
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Medical specialty
General, Plastic Surgery
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

For wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The Device is indicated for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.

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About this record

Negative Pressure Wound Therapy Powered Suction Pump is a medical device type in the General, Plastic Surgery 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.