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510(k) Data Aggregation

    K Number
    K130670
    Device Name
    HYDROFERA BLUE PU BACTERIOSTATIC DRESSING
    Manufacturer
    HYDROFERA, LLC.
    Date Cleared
    2014-01-02

    (296 days)

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

    HYDROFERA, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hydrofera Blue PU Antibacterial Wound Dressings are intended as external dressings for use in local management of wounds such as pressure ulcers, donor sites, venous stasis ulcers, arterial ulcers, diabetic ulcers, abrasions, lacerations, superficial burns, post-surgical incisions and other external wound inflicted by trauma.
    Device Description
    Hydrofera Blue PU Antibacterial Dressing is a sterile absorptive foam dressing made of bacteriostatic polyurethane (PU) foam, Methylene blue (less than or equal to 0.00035g/g) and Crystal violet {less than or equal to 0.00035g/g]. The Hydrofera Blue PU dressing is a dry absorbent wound dressing. The foam contains two antimicrobials that provide broad- spectrum antimicrobial protection in the foam: 1. Methylene Blue- a known inorganic antimicrobial/ antifungal, widely accepted to kill gram negative bacteria 2. Gentian Violet (Crystal violet) a known inorganic antimicrobial/antifungal widely accepted to kill gram positive bacteria
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    K Number
    K023138
    Device Name
    HYDROFERA BACTERIOSTATIC WOUND DRESSING
    Manufacturer
    HYDROFERA, LLC.
    Date Cleared
    2003-01-17

    (119 days)

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

    HYDROFERA, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hydrofera Bacteriostatic Wound Dressings are intended to use in the management of wounds such as minor cuts and scalds, abrasions, lacerations, and minor irritations of the skin. Please contact a Healthcare professional before using this product if you are unsure whether you have any of these conditions or if you are unsure what type of wound you have. Hydrofera BacteriostaticWound Dressings may also be used under the care of a Healthcare professional for use as external dressings in local management of wounds such as pressure ulcers, donor sites, venous stasis ulcers, arterial ulcers, díabetic ulcers, abrasions, lacerations, superficial burns, post surgical incisions, and other external wounds inflicted by trauma.
    Device Description
    Not Found
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    K Number
    K013462
    Device Name
    HYDROFERA BACTERIOSTATIC WOUND DRESSING
    Manufacturer
    HYDROFERA, LLC.
    Date Cleared
    2002-01-11

    (85 days)

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

    HYDROFERA, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hydrofera Bacteriostatic Wound Dressings are intended as external dressings for use in local management of wounds such as pressure ulcers, donor sites, venous stasis ulcers, arterial ulcers, disbetic ulcers, abrasions, lacerations, and superficial hi post-surgical incisions, and other external wounds inflicted by trauma.
    Device Description
    Hydrofera Bacteriostatic Wound Dressings are blue in color and manufactured from a pure white synthetic material with absorbent sponge-like characteristics. The two pigments have been added to render the material bacteriostatic.
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    K Number
    K983276
    Device Name
    HYDROFERA BACTERISTATIC NASAL DRESSING
    Manufacturer
    HYDROFERA, LLC.
    Date Cleared
    1999-09-14

    (362 days)

    Product Code
    EMX
    Regulation Number
    874.4100
    Why did this record match?
    Applicant Name (Manufacturer) :

    HYDROFERA, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    POST OPERATIVE PACKING AFTER SEPTAL RHINOPLASTIC, OR TURBINATE SURGERY.
    Device Description
    BACTERISTATIC NASAL DRESSING
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    K Number
    K974313
    Device Name
    HYDROFERA SURGICAL SPEAR
    Manufacturer
    HYDROFERA, LLC.
    Date Cleared
    1998-03-02

    (105 days)

    Product Code
    HOZ
    Regulation Number
    886.4790
    Why did this record match?
    Applicant Name (Manufacturer) :

    HYDROFERA, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hydrofera TM ophthalmic sponges are intended as external wicking device for use in local management of fluids during cataract surgery.
    Device Description
    Ophthalmic Sponge
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    K Number
    K974316
    Device Name
    HYDROFERA FEMORAL WICK
    Manufacturer
    HYDROFERA, LLC.
    Date Cleared
    1998-02-13

    (88 days)

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

    HYDROFERA, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The absorbent dressing is indicated for use in hip arthroplasty.
    Device Description
    Not Found
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