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510(k) Data Aggregation
K Number
K123449Device Name
BIOMONDE LARVAE
Manufacturer
Date Cleared
2013-03-05
(116 days)
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
BIOMONDE (A TRADING NAME OF ZOOBIOTIC LIMITED)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BioMonde Larval Debridement Therapy Products – Larvae 100/200/300 are indicated for debridement of non-healing necrotic skin and soft tissue wounds, including pressure ulcers, venous stasis ulcers, neuropathic foot ulcers, and non-healing traumatic or post-surgical wounds.
Device Description
The BioMonde Larvae 100/200/300 products are live larvae, stage I and II, of the green bottle fly Lucilia sericata. They are manufactured in three (3) configurations:
- Larvae100: at least 100 larvae per container
- Larvae200: at least 200 larvae per container .
- Larvae300: at least 300 larvae per container .
The larvae are derived from disinfected fly eggs. Larvae are transferred under controlled manufacturing conditions into transport tubes which are additionally boxed for transport. Upon arrival at the treatment location, they are applied to the wound and covered with permeable and absorbent dressings (not provided).
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