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510(k) Data Aggregation

    K Number
    K063190
    Device Name
    SILVERSEAL WOUND PACKING STRIPS WITH X-STATIC
    Manufacturer
    NOBLE FIBER TECHNOLOGIES, INC.
    Date Cleared
    2007-08-21

    (305 days)

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

    NOBLE FIBER TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Silverseal® Wound Packing Strips with X-Static® are intended for the control of local wound bleeding and nasal hemorrhage, and to encourage draining by wicking fluids from a body cavity, infected area, or abscess, and to help remove necrotic tissue from ulcers or other infected wounds when used as a wet-to-dry packing.
    Device Description
    SILVERSEAL® Wound Packing Strip with X-Static® is a flexible, non-adherent, protective dressing consisting of nylon fibers with a metallic silver surface. It is made of flexible, sterile, non-adherent fabric consisting of a knitted continuous nylon fiber substrate with a metallic silver surface containing approximately 1.5% silver oxide.
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    K Number
    K050726
    Device Name
    SILVERSEAL SILVERAID WITH X-STATIC
    Manufacturer
    NOBLE FIBER TECHNOLOGIES, INC.
    Date Cleared
    2005-12-05

    (262 days)

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

    NOBLE FIBER TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For over-the-counter use, SILVERSEAL® Adhesive Strips with X-Static® may be used for: First aid to help in minor abrasions, minor cuts, lacerations, scrapes, minor scalds and burns. Under the supervision of a health care professional, SILVERSEAL® Adhesive Strips may be used for the management of: SILVERSEAL® Adhesive Strips with X-Static® are sterile, non-adherent dressings intended for local management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic).
    Device Description
    SILVERSEAL® Adhesive Strips with X-Station are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. The silver provides effective protection of the dressing abainst microbial contamination. The nylon fabric permits the passage of exygen and fluids to and from the wound. The surface of the nylon fibers in SILVERSEAL® Adhesive Strips with X-Static; consists or a thin layer of approximately 22. metallic silver containing approximately 1.5 silver oxide that provides effective protection of the dressing against microbial contamination. SILVERSEAL: Adhesive Strips are made of flexible, sterile, non-adherent fabric consisting of a knitted continuous nylon fiber substrate with 22% metallic silver surface containing approximately 1.58 silver oxide.
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    K Number
    K051256
    Device Name
    SILVERSEAL ORTHOTIC COMPONENT WITH X-STATIC
    Manufacturer
    NOBLE FIBER TECHNOLOGIES, INC.
    Date Cleared
    2005-07-21

    (66 days)

    Product Code
    ISH
    Regulation Number
    890.3420
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOBLE FIBER TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SILVERSEAL® Orthotic Components with X-Static® are used as components on various orthotic devices intended for medical purposes that can be worn as a cervical collar or brace. The component comprises a knitted stockinette which is made of 90% cotton or polyester, and 10% X-Static®, which is 1.5% silver oxide. The component provides the skin with an antimicrobial barrier.
    Device Description
    SILVERSEAL® Orthotic Components with X-Static® are made of flexible, non-adherent fabric consisting of a knitted or made or in fabric which is 90% cotton or polyester, and 10% of a continuous nylon fiber substrate with a metallic silver surface containing approximately 1.5% silver oxide.
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    K Number
    K050649
    Device Name
    SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC
    Manufacturer
    NOBLE FIBER TECHNOLOGIES, INC.
    Date Cleared
    2005-06-13

    (91 days)

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

    NOBLE FIBER TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For over-the-counter use, Silverseal® Wound Contact Dressing with X-Static® may be used for first aid management of minor abrasions, cuts, scrapes, scalds and burns. Under the supervision of a health care professional, Silverseal® Contact Wound Dressing may be used for the management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure and diabetic).
    Device Description
    SILVERSEAL® Burn Contact Wound Dressings with X-Static® are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. The silver provides effective protection of the dressing against microbial contamination. The nylon fabric permits the passage of oxygen and fluids to and from the wound. The surface of the nylon fibers in SILVERSEAL® Contact Wound Dressings with X-Static® consists of a thin layer of metallic silver containing approximately 1.5% silver oxide that provides effective protection of the dressing against microbial contamination. SILVERSEAL® Contact Wound Dressings are made of flexible, sterile, non-adherent fabric consisting of a knitted continuous nylon fiber substrate with a metallic silver surface containing approximately 1.5% silver oxide.
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    K Number
    K043526
    Device Name
    SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC
    Manufacturer
    NOBLE FIBER TECHNOLOGIES, INC.
    Date Cleared
    2005-03-10

    (79 days)

    Product Code
    LGF
    Regulation Number
    888.5940
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOBLE FIBER TECHNOLOGIES, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K033900
    Device Name
    X-STATIC SILVERSEAL HYDROCOLLOID FILM AND ISLAND DRESSING
    Manufacturer
    NOBLE FIBER TECHNOLOGIES
    Date Cleared
    2005-01-14

    (394 days)

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

    NOBLE FIBER TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    X-Static® SILVERSEAL™ Hydrocolloid Film and Island Dressings indicated for: partial and full thickness dermal ulcers, leg ulcers (vascular, venous, pressure and diabetic), superficial wounds, abrasions, first and second degree burns, and donor sites.
    Device Description
    X-Static® SILVERSEAL™ Hydrocolloid Film and Island Dressings are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. Laboratory antibacterial testing has demonstrated that the silver provides effective protection of the dressing against microbial contamination. The nylon fabric permits the passage of oxygen and fluids to and from the wound. The surface of the nylon fibers in X-Static® SILVERSEAL™ Hydrocolloid Film and Island Dressing consists of a thin layer of metallic silver containing approximately 1.5% of 99% elemental silver that provides effective protection of the dressing against microbial contamination. Physical Description: 4 % x 4 % OD with a 2.5" x 2.0" square silver-colloid pad. The pad will consist of a colloid-film laminate, laminated to X-Static silver-plated nylon, number 90203.
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    K Number
    K033587
    Device Name
    SILVERSEAL
    Manufacturer
    NOBLE FIBER TECHNOLOGIES
    Date Cleared
    2004-08-05

    (266 days)

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

    NOBLE FIBER TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    X-Static® SILVERSEAL™ Contact Wound Dressings are sterile, non-adherent dressings intended for local management of partial thickness burns, incisions, skin grafts, donor sites, lacerations, abrasions, and Stage I-IV dermal ulcers (vascular, venous, pressure, and diabetic).
    Device Description
    X-Static® SILVERSEAL™ Contact Wound Dressings are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. The silver provides effective protection of the dressing against microbial contamination. The nylon fabric permits the passage of oxygen and fluids to and from the wound. The surface of the nylon fibers in X-Static® SILVERSEAL™ Contact Wound Dressing consists of a thin layer of metallic silver containing approximately 1% silver oxide that provides effective protection of the dressing against microbial contamination. X-Static® SILVERSEAL™ Contact Wound Dressings are made of flexible, sterile, non-adherent fabric consisting of 1 or 4 layers of a knitted continuous nylon fiber substrate with a metallic silver surface containing approximately 1% silver oxide.
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    K Number
    K040019
    Device Name
    SILVERSEAL
    Manufacturer
    NOBLE FIBER TECHNOLOGIES
    Date Cleared
    2004-07-23

    (199 days)

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

    NOBLE FIBER TECHNOLOGIES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The X-Static® Silverseal™ Hydrogel Wound Dressing is intended for the management of wounds and to provide an antimicrobial barrier. The dressing is indicated for use on partial and full thickness dermal ulcers, leg ulcers, superficial wounds, abrasions, first and second degree burns, donor sites and over debrided and grafted partial thickness wounds.
    Device Description
    X-Static® SILVERSEAL™ Hydrogel Wound Dressings are designed to intimately contact the wound as a primary dressing and permit the passage of fluids. The silver provides effective protection of the dressing against microbial contamination. The nylon fabric permits the passage of oxygen and fluids to and from the wound. The surface of the nylon fibers in X-Static® SILVERSEAL™ Hydrogel Wound Dressing consists of a thin layer of metallic silver containing approximately 1.5% silver oxide that provides effective protection of the dressing against microbial contamination. X-Static® SILVERSEAL™ ilydrogel Wound Dressings are made of flexible, sterile, non-adherent fabric consisting of 1 layer of a knitted continuous nylon fiber substrate with metallic silver surface containing approximately 1% silver oxide.
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