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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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