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510(k) Data Aggregation
K Number
K223377Device Name
BIASURGE Advanced Surgical Solution
Manufacturer
Date Cleared
2023-03-30
(146 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Rochal Technologies LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Biasurge Advanced Surgical Solution is indicated for use in mechanical cleansing and removal of debris, including microorganisms from wounds.
Device Description
BIASURGE Advanced Surgical Solution is a clear, colorless solution intended for cleansing and removal of debris, including microorganisms, from wounds. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of debris, including microorganism, from wounds. BIASURGE Solution is provided in a soft polypropylene 1000mL container with a spikeable port. BIASURGE Solution is composed of Purified Water, Poloxamer 407, Sodium Chloride, Ethylhexylglycerin, Hypromellose, Octane-1,2-diol, Polyaminopropyl Biguanide [PHMB; a preservative], EDTA Disodium, EDTA Trisodium.
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