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510(k) Data Aggregation

    K Number
    K161550
    Device Name
    DynaMesh-VENTRAL
    Manufacturer
    FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESELLSCHAFT
    Date Cleared
    2016-12-22

    (202 days)

    Product Code
    FTL, REG
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESELLSCHAFT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DynaMesh®-VENTRAL serves to support the tissue and stabilize the fascial structures of the abdominal wall. DynaMesh®-VENTRAL is indicated for repairing hernias in all current extraperitoneal surgical thecniques.
    Device Description
    The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh®-VENTRAL is a textile structure knitted from non absorbable, bio-stable Polyvinylidene fluoride (PVDF) monofilament fiber. The grade of Polyvinylidene Fluoride (PVDF) used is SOLEF®1008 of Solvay Solexis. The knitted mesh structure consists of uncoloured PVDF Monofilaments with a zig-zag pattern of green-coloured PVDF Monofilaments as visual aid to the clinician that facilitates correct mesh positioning; the mesh is correctly positioned when the ziqzag-stripes are in the craniocaudal direction. The used green dye is Phtalocyanine green, CAS1328-53-6,PG7 of BASF. DvnaMesh®-VENTRAL is supplied as a sterile, flat sheet of material without any coatings. The FEG Textiltechnik's DynaMesh®-VENTRAL will be packed in a cardboard box. Within the cardboard box the device will be double-packed in two paper-poly pouches suitable for Ethylene Oxide sterilization; the labeled outer pouch contains the inner pouch and four adhesive labels for use on patient records.
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    K Number
    K131530
    Device Name
    DYNAMESH -CICAT
    Manufacturer
    FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESEL
    Date Cleared
    2013-10-23

    (148 days)

    Product Code
    FTL, REG
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESEL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DynaMesh®-CICAT serves to support the tissue and stabilize the fascial structures of the abdominal wall. DynaMesh®-CICAT is indicated for repairing incisional hernias in all current extraperitoneal surgical techniques.
    Device Description
    The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh®-CICAT is a textile structure knitted from non absorbable, bio□ stable Polyvinylidene fluoride (PVDF) monofilament fiber. Polyvinylidene Fluoride (PVDF) has been used for approximately 20 years for long-term implants in cardiac and vascular surgery because of its biocompatibility and durability. PVDF is a high performance polymer material with very high material purity. The grade of Polyvinylidene Fluoride (PVDF) used is SOLEF®1008 of Solvay Solexis. The knitted mesh structure consists of uncoloured PVDF Monofilaments with a pattern of zig-zag marking stripes as visual aid to the clinician facilitating correct mesh positioning; the mesh is correctly positioned when the zig-zag stripes are in the craniocaudal direction. DynaMesh®-CICAT is supplied as a sterile, flat sheet of material without any coatings or additives. The FEG Textiltechnik's DynaMesh®-CICAT will be packed in a cardboard box. Within the cardboard box the device will be double-packed in two paper-poly pouches suitable for Ethylene Oxide sterilization; the labeled outer pouch contains the inner pouch and four adhesive labels for use on patient records.
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    K Number
    K073579
    Device Name
    DYNAMESH-PP STANDARD, MODEL PP02NNNN, DYNAMESH-PP LIGHT, MODEL PP01NNNN
    Manufacturer
    FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESEL
    Date Cleared
    2008-08-18

    (242 days)

    Product Code
    FTL, REG
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESEL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DynaMesh-PP is a polypropylene mesh intended to support tissue and stabilize fascial structures of the abdominal wall. DynaMesh-PP is indicated for repairing hernias, parietal reinforcement of tissues and abdominal wall repair.
    Device Description
    The FEG Textiltechnik Forschungs- und Entwicklungsgesellschaft mbH DynaMesh-PP is a polypropylene mesh, knitted from non absorbable, bio-stable, polypropylene monofilament fiber. DynaMesh-PP is supplied as a sterile, flexible, flat sheet of material. DynaMesh-PP is intended for use during hernia surgery, where the flat sheet can be cut to size, based on patient specific anatomical requirements. FEG Textiltechnik's DynaMesh-PP will be available in two mesh densities, standard and light, and a variety of sizes. The FEG Textiltechnik DynaMesh-PP will be packaged double-packed in two transparent plastic bags: - the inner transparent bag contains the device only - the outer transparent bag contains the inner bag and four adhesive labels for patient records. The product label will be on the outer bag, which is then protected by a cardboard box. The product has a stated shelf-life of 3 years which is supported by real-time testing.
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