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510(k) Data Aggregation

    K Number
    K143151
    Device Name
    Cutimed Sorbact Wound Dressings (Cutimed Sorbact Hydroactive, Cutimed Sorbact Hydroactive B, Cutimed Siltec Sorbact)
    Manufacturer
    Date Cleared
    2015-01-26

    (84 days)

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

    BSN MEDICAL GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Cutimed® Sorbact® Hydroactive is indicated for use in the management of low to moderate exuding 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, Cutimed® Sorbact® Hydroactive B is indicated for use in the management of low to moderate exuding partial to full thickness wounds (including clean, colonized, contaminated, or infected wounds (yenous and arterial ulcers, diabetic ulcers and pressure ulcers), postoperative dehisced wounds and traumatic wounds. Cutimed® Siltec Sorbact® is indicated for use in the management of moderate to heavily exuding partial to full thickness wounds (including clean, colonized, or infected wounds): chronic wounds (venous and arterial ucers, diabetic ulcers and pressure ulcers), postoperative dehisced wounds and traumatic wounds.
    Device Description
    Cutimed® Sorbact® Wound Dressings combine Sorbact mesh (Sorbact acetate fabric coated with dialkylcarbamoylchloride - DACC) with a highly absorbent hydropolymer matrix or superabsorbent polyurethane foam and are covered by a semi-permeable polyurethane film. A fixation border is made of a latex free hydrogel or silicone adhesive. The dressings come in three models (Cutimed® Sorbact® Hydroactive, Cutimed® Sorbact® Hydroactive B, Cutimed® Siltec Sorbact®), multiple sizes in each model and are sterile and single use.
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