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510(k) Data Aggregation

    K Number
    K040339
    Device Name
    BRACHYTHERAPY STRAND DEVICE
    Manufacturer
    BEBIG ISOTOPEN-UND MEDIZINTECHNIK GMBH
    Date Cleared
    2004-04-08

    (57 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    BEBIG ISOTOPEN-UND MEDIZINTECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BEBIG I-125 sources are intended for use in the treatment of turnors, with radioactive sources within or in close proximity to the turnor. The Brachytherapy Strand Device is indicated for tumors with any of the following characteristics: - Localized - Unresectable - Low to Moderate Radiosensitivity The tumors may be of the following type: - Superficial - Intrathoracic - Intra-abdominal - Lung, Pancreas, Prostate, Head and Neck - Residual following external beam radiation or excision of primary tumor - Recurrent
    Device Description
    The Brachytherapy Strand Device is used for the treatment of localized tumors and is placed into a body cavity or tissue. It consists of a pre-sterilized kit containing a prostate seeding needle and a custom-loaded strand of seeds spaced at a precise distance within absorbable suture. The spacers are made from the same material as the sutures. The customized strand can contain a variable number (1-12) of seeds and/or seeding spacers (maximum 12 components per strand). The stranded Pd-103 and I-125 implants are placed inside the needle. The needle is made from 18 gauge stainless steel
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    K Number
    K033781
    Device Name
    BEBIG ISOSEED I-125
    Manufacturer
    BEBIG ISOTOPEN-UND MEDIZINTECHNIK GMBH
    Date Cleared
    2003-12-30

    (26 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    BEBIG ISOTOPEN-UND MEDIZINTECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BEBIG I-125 sources are intended for use in the treatment of cancer with radioactive sources in close proximity to or within the tumor. The BEBIG brachytherapy I-125 sources are indicated for the treatment of selected localized tumors. These sources are commonly used to treat superficial, intra-abdominal and intrathoracic tumors. Tumors of the head, neck, lung, pancreas and prostate are commonly treated. They may be used alone, or in combination with external beam radiation.
    Device Description
    The BEBIG I-125 sources are cylindrical sealed sources containing iodine-125 radioactivity. The sources are 4.5 mm long and 0.8 mm in diameter. The outer capsule of the source is composed of titanium, and is sealed at each end by laser weld. The iodine-125 is deposited within a porous ceramic tube as silver iodide (AgI). A radiopaque marker is located in the center of the ceramic tube to serve as an x-ray marker. The radiopaque marker is composed of gold alloy. I-125 has a half live of 59.46 days and decays by electron capture with emission of characteristic photons and electrons. The titanium wall of the 1-125 source absorbs the electrons. The BEBIG I-125 sources are available in a range of activity levels. The most commonly used source activity levels for permanent implants are 0.2-0.6 mCi, other source strengths, in particular for temporary applications, are available according to customer specific order. The sources are provided non-sterile and must be sterilized before use.
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    K Number
    K021343
    Device Name
    ISOSEEDS I-125
    Manufacturer
    BEBIG ISOTOPEN-UND MEDIZINTECHNIK GMBH
    Date Cleared
    2002-05-20

    (21 days)

    Product Code
    KXK
    Regulation Number
    892.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    BEBIG ISOTOPEN-UND MEDIZINTECHNIK GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BEBIG I-125 sources are intended for use in the treatment of cancer with radioactive sources in close proximity to or within the tumor. The BEBIG brachytherapy I-125 sources are indicated for the treatment of selected localized turnors. These sources are commonly used to treat superficial, intra-abdominal and intrathoracic tumors. Tumors of the head, neck, lung, pancreas and prostate are commonly treated. They may be used alone, or in combination with external beam radiation.
    Device Description
    The BEBIG I-125 sources are cylindrical sealed sources containing iodine-125 radioactivity. The sources are 4.5 mm long and 0.8 mm in diameter. The outer capsule of the source is composed of titanium, and is sealed at each end by laser weld. The iodine-125 is deposited within a porous ceramic tube as silver iodide (AgI). A radiopaque marker is located in the center of the ceramic tube to serve as an x-ray marker. The radiopaque marker is composed of gold alloy. I-125 has a half live of 59.46 days and decays by electron capture with emission of characteristic photons and electrons. The titanium wall of the I-125 source absorbs the electrons. The BEBIG I-125 sources are available in a range of activity levels. They are provided nonsterile and must be sterilized before use.
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