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510(k) Data Aggregation

    K Number
    K250864

    Validate with FDA (Live)

    Date Cleared
    2025-12-19

    (273 days)

    Product Code
    Regulation Number
    N/A
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    MatriDerm pluS+ is indicated for the management of wounds including full thickness and partial thickness wounds, chronic wounds (e.g. pressure ulcers, venous ulcers, diabetic ulcers, chronic ulcers), surgical wounds (donor sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), partial thickness burns, trauma wounds (abrasions, lacerations and skin tears) and draining wounds.

    Device Description

    MatriDerm pluS+ Bi-Layer is a non-pyrogenic, single use, prescription use three-dimensional dermal matrix consisting of two layers. The first layer is composed of collagen fibers, a key component of the native extracellular matrix, and hydrolyzed elastin. The second layer consists of a medical grade silicone grid to control moisture loss from the wound providing a flexible adherent covering for the wound surface and adding increased mechanical strength to the device. The device conforms in the defect space / wound bed and includes a fibrous, porous structure that allows for fluid absorption. The device serves as a scaffold for cellular invasion and capillary growth and promotes a moist environment for the body's natural healing process. The device is supplied sterile and is provided in different sizes providing flexibility of choice based on the treatment protocol, wound location, size, and depth.

    AI/ML Overview

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