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    K Number
    K170213
    Device Name
    SupraSDRM Biodegradable Matrix Wound Dressing
    Manufacturer
    PolyMedics Innovations GmbH
    Date Cleared
    2017-06-28

    (155 days)

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

    PolyMedics Innovations GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The SupraSDRM Biodegradable Matrix Wound Dressing is indicated for use in the management of: - Partial and full thickness wounds - Pressure (stage I and IV) and venous ulcers - Ulcers caused by mixed vascular etiologies - Venous stasis and diabetic ulcers - 1st and 2nd degree burns - Partial thickness burns - Cuts and abrasions - Acute wounds - Trauma wounds - Surgical wounds - Superficial wounds - Grafted wounds and donor sites
    Device Description
    The SupraSDRM Biodegradable Matrix Wound Dressing is a tri-polymer, Biodegradable dermal covering that is provided in a flat sheet. The SupraSDRM Biodegradable Matrix Wound Dressing can be cut with scissors to the desired shape and size. The SupraSDRM Biodegradable Matrix Wound Dressing is fully malleable at room temperature and becomes more pliable at body temperature and thus can be conformed three dimensionally to most any anatomical orientation. The SupraSDRM Biodegradable Matrix Wound Dressing can be used either alone or in conjunction with a petroleum jelly and/or gauze wound and burn dressing which can also serve to further secure the SupraSDRM Biodegradable Matrix Wound Dressing and prevent dislocation. The PolyMedics Innovations (PMI) SupraSDRM Biodegradable Matrix Wound Dressing is provided in various shapes such as rectangles, ovals, and circles and will be provided in other shapes and sizes as needed for particular wound and burn-care applications. The PolyMedics Innovations (PMI) SupraSDRM Biodegradable Matrix Wound Dressing is provided in sheets of 50mm x 50mm to 180mm to 230mm and will be provided in other shapes and sizes as needed for particular burn and wound-care applications. The thickness of the PolyMedics (PMI) SupraSDRM Biodegradable Matrix Wound Dressing ranges from 1,500um to 2,100um according to the region to be treated. The PolyMedics Innovations (PMI) SupraSDRM Biodegradable Matrix Wound Dressing is provided in solid sheets that contain micropores that range in size from 13um to 300um.
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    K Number
    K090160
    Device Name
    SUPRATHEL WOUND AND BURN DRESSING
    Manufacturer
    POLYMEDICS INNOVATIONS GMBH
    Date Cleared
    2009-05-20

    (118 days)

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

    POLYMEDICS INNOVATIONS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Suprathel Wound and Burn Dressing is indicated for temporary coverage of non-infected skin defects, such as superficial wounds, under sterile conditions. The dressing is intended to maintain a moist wound healing environment. A moist wound healing environment allows autolytic debridement. The Suprathel Wound and Burn Dressing is used in the management of: - · Partial and full thickness wounds - · Pressure (stage I and IV) and venous ulcers - · Ulcers caused by mixed vascular etiologies - · Venous stasis and diabetic ulcers - · 1st and 2nd degree burns - Partial thickness burns - · Cuts and abrasions - · Acute wounds - · Trauma wounds - · Surgical wounds - · Superficial wounds - · Grafted wounds and donor sites
    Device Description
    The Suprathel Wound and Burn Dressing is a tri-polymer, bioresorbable dermal covering that is provided in a flat sheet. The Suprathel Wound and Burn Dressing can be cut with scissors to the desired shape and size. The Suprathel Wound and Burn Dressing is fully malleable at room temperature and becomes more pliable at body temperature and thus can be conformed three dimensionally to most any anatomical orientation. The Suprathel Wound and Burn Dressing can be used either alone or in conjunction with various conventional gauze dressings with and without fatty additives, which can also serve to further secure the Suprathel Wound and Burn Dressing and prevent dislocation. The PolyMedics Innovations (PMI) Suprathel Wound and Burn Dressing is provided in various shapes such as rectangles, ovals, and circles and will be provided in other shapes and sizes as needed for particular wound and burn-care applications. The PolyMedics Innovations (PMI) Suprathel Wound and Burn Dressing is provided in sheets of 50mm x 50mm to 180mm to 230mm and will be provided in other shapes and sizes as needed for particular burn and wound-care applications. The thickness of the PolyMedics Innovations (PMI) Suprathel Wound and Burn Dressing ranges from 50um to 200um according to the region to be treated. The PolyMedics Innovations (PMI) Suprathel Wound and Burn Dressing is provided in solid sheets that contain micropores that range in size from 2um to 50μ. Material Composition The Suprathel Wound and Burn Dressing is frabricated from a tri-polymer of polylactide. trimethylene carbonate, and e-caprolactone.
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