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Dermapose Access
Bimini Technologies LLC · Model ACCESS · UDI-DI 00850034511306
QPB
Prescription
10
510(k) clearances
71
Adverse events
1
Recalls
49
Facilities
Description
A pre-assembled, sterile, single use system intended to assist the harvesting of autologous fat grafts from a patient for aesthetic body contouring. It creates a guided incision for cannula introduction at a controlled depth (10 mm) under the skin for the purpose of small volume adipose tissue harvest.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-18 | HUMAN MED AG | The cannula tubes do not comply with the specification. The water jet emerging from the nozzle of the nonconforming cannulas may emerge as a spot jet rather than a fan-shaped spra |
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