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510(k) Data Aggregation

    K Number
    K232204
    Device Name
    ReyaGel (RG03 - MTP gel 3mL)
    Manufacturer
    Date Cleared
    2024-04-19

    (269 days)

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

    FetTech

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    ReyaGel is intended for the management of wounds that include: - · Partial and full thickness wounds - · Pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers - · Second degree burns - · Surgical wounds donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence - · Trauma wounds abrasions, lacerations, and skin tears - · Tunneled/undermined wounds - · Draining wounds
    Device Description
    ReyaGel Wound Gel is an extracellular matrix wound product composed of porcine spleen and lung extracellular matrix in a saline gel, for the management of wounds. It is an off-white gel supplied in a syringe for topical application. The product is provided sterile for single use.
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