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510(k) Data Aggregation

    K Number
    K232758
    Device Name
    Comatryx OTC
    Manufacturer
    Strukmyer Medical, LLC.
    Date Cleared
    2023-12-01

    (84 days)

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

    Strukmyer Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for the management of minor scrapes, minor bruises, minor abrasions, minor lacerations, and minor burns.
    Device Description
    CoMatryx OTC Collagen Wound Dressing is a native bovine Type I Collagen which, when applied to a wound surface in powder or pad form, absorbs wound fluid and maintains a moist wound environment. The CoMatryx OTC powder and pads are provided sterile in the following configurations: - . 1 gram powder in 1 pouch - 2"x2," 3"x4," and 8"x12" pad in pouch
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    K Number
    K171645
    Device Name
    CoMatryx Collagen Wound Dressing 1 gram pouch, CoMatryx Collagen Wound Dressing 1 gram vial, CoMatryx Collagen Wound Dressing 10 gram bottle
    Manufacturer
    Strukmyer Medical
    Date Cleared
    2017-07-25

    (50 days)

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

    Strukmyer Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CoMatryx Collagen Wound Dressing may be used in the management of partial and full thickness wounds, pressure (stage I-IV) and venous ulcers, ulcers caused by mixed vascular etiologies, venous stasis and diabetic ulcers, 1st and 2nd degree burns, cuts, abrasions, and surgical wounds.
    Device Description
    Collagen Wound Dressing, a native bovine Type I Collagen which, when applied to a wound surface, absorbs wound fluid and maintains a moist wound environment in the management of wound healing. The CoMatryx Collagen Wound Dressing is provided sterile in the following patient ready configurations: - 10 gram Bottle - 1 gram Vial - 1 gram pouch
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    K Number
    K161311
    Device Name
    USP Sterile Water, 120 mL cup, USP Sterile Normal Saline (0.9% sodium chloride), 120 mL cup, USP Sterile Water, 100 mL,250 mL and 500 mL bottles, USP Sterile Normal Saline (0.9% sodium chloride), 100 mL, 250 mL and 500 mL bottles
    Manufacturer
    STRUKMYER MEDICAL LLC
    Date Cleared
    2016-08-29

    (111 days)

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

    STRUKMYER MEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For Over-the-Counter Use: For moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin. For Prescription Use: For moistening absorbent wound dressings and for moistening, debriding and cleaning acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second degree burns, cuts, abrasions and minor skin irritations and for device irrigation.
    Device Description
    The Sterile Water and Sterile Normal Saline devices are wound and device cleaning solutions that are intended for moistening and debriding of dermal wounds and for device irrigation. The solution is either sterile water or sterile normal saline for irrigation and meets the requirements of USP <38>. The devices are offered in 100 mL, 250 mL and 500 mL bottles and 120 mL cups
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