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510(k) Data Aggregation

    K Number
    K171225
    Device Name
    Sorbact Wound Dressing-Ribbon Gauze
    Manufacturer
    Date Cleared
    2017-08-21

    (117 days)

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

    ABIGO Medical AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Sorbact® Ribbon Gauze is intended for use in the management of exuding partial to full thickness wounds (including clean, colonized, contaminated or infected wounds). Sorbact® Ribbon Gauze is indicated for shallow cavity wounds and fistulas.
    Device Description
    Sorbact® Ribbon Gauze is a sterile (gamma irradiation), single use only, hydrophobic microbe binding wound dressing. It consists of a Sorbact® wound contact layer, which allows passage of wound exudate into a secondary dressing.
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    K Number
    K153674
    Device Name
    Sorbact Foam Gentle Border, Sorbact Superabsorbent
    Manufacturer
    Date Cleared
    2016-07-01

    (193 days)

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

    ABIGO Medical AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Rx.: Sorbact® Foam Gentle Border is inthe management of moderately exuding partial to full thickness wounds (including clean, colonized, or infected wounds): chronic wounds (venous and arterial ulcers, diabetic ulcers and pressure ulcers), postoperative dehisced wounds and traumatic wounds. Rx.: Sorbact® Superabsorbent is indicated for use in the management of heavily partial to full thickness wounds (including clean, colonized, contaminated, or infected wounds (venous and arterial ulcers, diabetic ulcers and pressure ulcers), postoperative dehisced wounds and traumatic wounds.
    Device Description
    Sorbact® Absorbent Dressings come in two models, Sorbact® Foam Gentle Border and Sorbact® Superabsorbent, for use with moderately or heavily exuding wounds, respectively. Both dressings come in multiple sizes, are sterile (EO), hydrophobic microbe binding, and for single use only. The dressings combine a Sorbact® wound contact layer with absorbent polyurethane foam or a superabsorbent core. The dressings are covered by a semi-permeable polyurethane film or polypropylene non-woven. A fixation border is made of silicone adhesive.
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    K Number
    K100591
    Device Name
    SORBACT
    Manufacturer
    Date Cleared
    2011-01-24

    (328 days)

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

    ABIGO MEDICAL AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    OTC: Sorbact Gel Wound Dressing is intended for use in the management of minor wounds (dry to low exuding) and to attract water repelling germs. The dressing may be used on minor scrapes, cuts, sores and burns. Rx: Sorbact Gel Wound Dressing is intended for use in the management of dry to low exuding partial to full thickness wounds (including clean, colonized, contaminated or infected wounds). The dressing is indicated for post-operative wounds, trauma wounds, shallow cavity wounds, fistulas, pressure ulcers, diabetic ulcers, and venous ulcers.
    Device Description
    Sorbact® gel Wound Dressings are sterile bandages that attract and capture water-repelling (hydrophobic) microorganisms.
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    K Number
    K063059
    Device Name
    SORBACT WOUND DRESSING
    Manufacturer
    Date Cleared
    2007-04-19

    (196 days)

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

    ABIGO MEDICAL AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Rx: Sorbact® Wound Dressings are intended for use in the management of moderate to heavily exudating partial to full thickness wounds (including clean, colonized, contaminated or infected wounds) and to bind hydrophobic microbes The dressing is indicated for post-operative wounds, trauma wounds, shallow cavity wounds, fistulas, pressure ulcers, diabetic ulcers, and venous ulcers. OTC: Sorbact® Wound Dressings are intended for use in the management of draining minor wounds and to attract and bind water repelling germs. The dressing may be used on minor scrapes, cuts, sores and burns.
    Device Description
    Sorbact Wound Dressings are sterile bandages that attract and capture water-repelling (hydrophobic) microorganisms. The dressings are coated with DACC (dialky) carbamoyl chloride), a hydrophobic (water-repelling) fatty ester acid that binds to and reduces the overall concentration of hydrophobic microbes in a wound each time the dressing is changed. Available Sorbact products include adsorbent dressings, compresses, ribbon gauze tamponades, round swabs and surgical dressings.
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