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510(k) Data Aggregation

    K Number
    K083721
    Device Name
    MODIFICATION TO ZENIEVA
    Manufacturer
    RIVER'S EDGE PHARMACEUTICALS, LLC
    Date Cleared
    2009-01-08

    (24 days)

    Product Code
    NAE
    Regulation Number
    878.4022
    Why did this record match?
    Product Code :

    NAE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Zenieva is used to manage and relieve the burning and itching experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis, and allergic contact dermatitis. Zenieva helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
    Device Description
    Zenieva is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for prescription (requires a physician diagnosis of disease state) use. The product is formulated as an oil-in-water emulsion containing a cross-linked polyacrylic acid polymer, natural gum, and cellulose as thickening agents. The oil composition of Zenieva is composed of glyceride, squalane, lecithin, and fatty acids.
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    K Number
    K082865
    Device Name
    MODIFICATION TO ZENIEVA
    Manufacturer
    GORBEC PHARMACEUTICAL SERVICES, INC.
    Date Cleared
    2008-10-23

    (24 days)

    Product Code
    NAE
    Regulation Number
    878.4022
    Why did this record match?
    Product Code :

    NAE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Zenieva is used to manage and relieve the burning and itching experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis, and allergic contact dermatitis. Zenieva helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
    Device Description
    Zenieva is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for prescription (requires a physician diagnosis of disease state) use. The product is formulated as an oil-in-water emulsion containing a crosslinked polyacrylic acid polymer, natural gum, and cellulose as thickening agents. The oil composition of Zenieva is composed of glyceride, squalane, lecithin, and fatty acids.
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    K Number
    K073246
    Device Name
    ZENIEVA
    Manufacturer
    GORBEC PHARMACEUTICAL SERVICES, INC.
    Date Cleared
    2008-07-23

    (247 days)

    Product Code
    NAE
    Regulation Number
    878.4022
    Why did this record match?
    Product Code :

    NAE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Zenieva is used to manage and relieve the burning and itching experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis, and allergic contact dermatitis. Zenieva helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.
    Device Description
    Zenieva is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for prescription (requires a physician diagnosis of disease state) use. The product is formulated as an oil-in-water emulsion containing a crosslinked polyacrylic acid polymer, natural gum, and cellulose as thickening agents. The oil composition of Zenieva is composed of glyceride, squalane, lecithin, and fatty acids.
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    K Number
    K992094
    Device Name
    GILTECH PLUS HYDROGEL SKIN DRESSING
    Manufacturer
    GILTECH PLUS, INC.
    Date Cleared
    1999-09-17

    (88 days)

    Product Code
    NAE, MGQ
    Regulation Number
    878.4022
    Why did this record match?
    Product Code :

    NAE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Giltech Plus Hydrogel Wound Dressing is intended to be used in the management of. 1. Minor burns 2. Decubitus ulcers 3. Superficial lacerations, cuts and abrasions 4. Postoperative incisions 5. Sunburn
    Device Description
    This hydrogel retains cold temperature. Its' high specific heat, due to high water content, allows it to have a cooling effect.
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    K Number
    K991061
    Device Name
    DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING
    Manufacturer
    DERMAPHYLYX, INC.
    Date Cleared
    1999-06-28

    (90 days)

    Product Code
    NAE, MGQ
    Regulation Number
    878.4022
    Why did this record match?
    Product Code :

    NAE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dermaphylyx Calcium Alginate Wound Dressings are intended for use in the management of a variety of partial and full-thickness wounds. The dressings are additionally intended to help control minor bleeding. The following Indications are for Prescription Use or under the direction of a health care professional: - Venous ulcers - Diabctic ulcers - Pressure ulcers - Arterial ulcers - Superficial burns - Abrasions and lacerations - Donor sites - Postoperative wounds The following Indications are for Over-the-Counter Use: - Abrasions - Minor Burns - Minor Cuts - Minor Lacerations
    Device Description
    Dermaphylyx Calcium Alginate Wound Dressings consist of calcium alginate fibers fabricated into felt and rope configurations. Dermaphylyx Calcium Alginate Wound Dressings are engineered to absorb substantial quantities of wound cxudate. During the absorption of exudate the dressing forms a gel/liber mat. The formation of the gel/fiber mat may help facilitate removal from the wound.
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    K Number
    K972646
    Device Name
    AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES
    Manufacturer
    LUDLOW TECHNICAL PRODUCTS
    Date Cleared
    1997-08-21

    (37 days)

    Product Code
    NAE, MGQ
    Regulation Number
    878.4022
    Why did this record match?
    Product Code :

    NAE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This hydrogel dressing is a sterile wound dressing for the management of partial thickness wounds, first and second degree burns, donor sites and superficial injuries. Ad-Heal™ Bydrogel Dressing is indicated for: First and Second Degree Burns Partial Thickness Wounds Donor Sites Pressure Ulcers Abrasions Note: Ad-Healm is not indicated for full thickness or infected wounds or for third degree burns. This is a disposable, short term (less than 72 hours between changes) device for single patient use
    Device Description
    This hydrogel dressing is a sterile wound dressing for the management of partial thickness wounds, first and second degree burns, donor sites and superficial injuries. This is a disposable, short term (less than 72 hours between changes) device for single patient use
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    K Number
    K971597
    Device Name
    COMFEEL PURILON GEL,15G(3900)/COMFEEL PURILON GEL,25G(3903)
    Manufacturer
    COLOPLAST CORP.
    Date Cleared
    1997-07-29

    (89 days)

    Product Code
    NAE, MGQ
    Regulation Number
    878.4022
    Why did this record match?
    Product Code :

    NAE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in the management of leg ulcers and pressure sores. The gel provides a moist wound healing environment which encourages natural autolytic debridement.
    Device Description
    Comfeel® Purilon Gel is an absorbent hydrogel wound dressing composed of calcium alginate, sodium carboxymethylcellulose and purified water. The product is supplied sterile in 15 g and 25 g plastic bellow tubes.
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    K Number
    K962352
    Device Name
    HYDROGEL SKIN DRESSING
    Manufacturer
    NORTH AMERICAN STERILIZATION & PACKAGING CO.
    Date Cleared
    1996-08-02

    (45 days)

    Product Code
    NAE
    Regulation Number
    878.4022
    Why did this record match?
    Product Code :

    NAE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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