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510(k) Data Aggregation

    K Number
    K190246
    Device Name
    NeuroShield
    Date Cleared
    2019-05-31

    (114 days)

    Product Code
    Regulation Number
    882.5275
    Why did this record match?
    Applicant Name (Manufacturer) :

    Monarch Bioimplants GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Under supervision of a healthcare professional · NeuroShield[TM] is indicated for the repair of peripheral nerve injuries in which there is no gap or where a gap closure can be achieved by flexion of the extremity.
    Device Description
    NeuroShield™ is a chitosan membrane to provide a non-constricting protection for peripheral nerves. NeuroShield™ is designed to be an interface between the nerve and the surrounding tissue for uses to treat nerve injuries. When hydrated, NeuroShield™ is easy to handle, soft, pliable, nonfriable, porous and transparent. NeuroShield™ is provided as a sterile, non-pyrogenic rectangular sheet in the size of 40 x 30 x 0.03 mm and is intended for single use. NeuroShield™ is perforated to support the transport of physiological liquid through the wall of the device thereby easing the attachment to nerve tissue. With a diameter of 0.2 mm the holes make up 0.8% of the surface area of NeuroShield™. NeuroShield™ can easily be placed over the injured nerve, and can be sutured if necessary. Furthermore, the device can be trimmed or shaped to the appropriate size to fit the nerve tissue to be treated.
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