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UltraMIST Applicator

ALLIQUA BIOMEDICAL, INC. · Model CP-80034 · UDI-DI 00816789010235

NRB Prescription
1
510(k) clearances
22
Adverse events (1 deaths)
0
Recalls
10
Facilities

Description

A sterile component of a wound therapy ultrasound system intended to be attached to the system treatment wand to interface low frequency ultrasound energy from the treatment wand with a fluid solution (e.g., saline) for the production of an ultrasound-conductive mist used to promote wound healing. It typically includes fluid delivery tubing and is intended to fit on the distal end of the treatment wand. This is a single-use device.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.