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Wound Cleaner, Ultrasound

FDA product code NRB · 6 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.4410
Review panel
SU
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
2005-05-17 – 2016-12-22

The ultrasound wound cleaner/mild debridement system is a device that delivers a cleaning fluid to the wound that is pulsed using low power ultrasound radiation. The device is intended to clean and mildly debride wounds. The ultrasound generator must deliver 1.0 mw/cm2 or less energy to the wound

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