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510(k) Data Aggregation

    K Number
    K100693
    Device Name
    AQUANOVA AG SUPER ABSORBANT DRESSING, AQUANOVA AG ANTIMICROBIAL DRESSING
    Manufacturer
    MEDTRADE PRODUCTS LIMITED
    Date Cleared
    2010-08-10

    (152 days)

    Product Code
    FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRADE PRODUCTS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Under the supervision of a healthcare professional AQUANOVA Ag may be used for the management of partial and full thickness wounds 15 and 200 degree burns, diabetic foot ulcers, venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology and pressure ulcers/sores (partial and full thickness), surgical wounds and donor sites.
    Device Description
    AQUANOVA Ag Super-Absorbent Dressing (Silver containing Antibacterial Dressing) is a soft, sterile, nonwoven pad or ribbon dressing is composed of Chitosan derivative materials with the addition of ionic silver ions. The ionic silver ions present in the dressing help to inhibit bacterial growth in the dressing. The dressing absorbs wound fluid and exudate and creates a soft, cohesive gel that intimately conforms to the wound bed and creates a moist wound healing environment conducive to wound healing and aids in the removal of non-viable tissue from the wound (autolytic debridement).
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    K Number
    K093593
    Device Name
    CELOX PRO, CELOX PRO OTC, CELOX HEMOSTATIC GRANULES, CELOX PRO HEMOSTATIC GRANULES, OMNI STAT PRO
    Manufacturer
    MEDTRADE PRODUCTS LIMITED
    Date Cleared
    2010-01-20

    (62 days)

    Product Code
    QSY, FRO
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDTRADE PRODUCTS LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CELOX PRO for minor external bleeding from wounds and procedures (Rx) is indicated for use as a temporary topical dressing for bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures. CELOX PRO for moderate to severe external bleeding wounds (Rx) is indicated for temporary external treatment for controlling moderate to severe bleeding. CELOX PRO for minor external bleeding from wounds and procedures (OTC) is indicated for use as a temporary topical dressing for bleeding control associated with minor wounds, including control of minor external bleeding and exudate from sutures and/or surgical procedures.
    Device Description
    Components - CELOX PRO is composed of chitosan, polymer, poly-N-acetyIglucosamine. Mechanism of Action – CELOX Pro achieves its principle intended action (hemostasis) by creating a physical barrier or seal to stop the flow of blood. When poured on a wound and upon contact with blood or exudate, in combination with manual pressure to the wound. CELOX PRO quickly forms a strong seal that completely covers the wound.
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