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510(k) Data Aggregation

    K Number
    K042580
    Device Name
    TIDI BRAND STERILIZATION WRAP
    Date Cleared
    2004-11-17

    (56 days)

    Product Code
    Regulation Number
    880.6850
    Why did this record match?
    Applicant Name (Manufacturer) :

    BANTA HEALTHCARE GROUP, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Tidi brand Sterilization/CSR Wrap is suitable for both medical and dental facilities as a wrapping material for sterilizing instruments and equipment. Available in numerous sizes, CSR wrap is a single-use product intended for use in steam and ethylene oxide sterilization applications. The wraps maintain their wrapped integrity after sterilization to maintain contents' sterility before use. CSR Wraps can also be used for many needs that do not require sterilization, such as draping a tray and acting as a protective sheet between a surface and instruments.
    Device Description
    The Banta Healthcare Group Tidi Brand Sterilization/CSR Wrap is suitable for both medical and dental facilities as a wrapping material for sterilizing instruments and equipment. The Sterilization/CSR Wrap is made from a blue, wet formed nonwoven fabric comprised of natural wood pulp fibers bonded with a synthetic resin binder and is available in numerous sheet sizes. Sterilization/CSR Wrap is a single-use product intended for use in steam and ethylene oxide sterilization applications.
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    K Number
    K003749
    Device Name
    100% 30G POLYPROPYLENE SPUNBOND ISLATION GROWN
    Manufacturer
    Date Cleared
    2001-02-23

    (81 days)

    Product Code
    Regulation Number
    878.4040
    Why did this record match?
    Applicant Name (Manufacturer) :

    BANTA HEALTHCARE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
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    K Number
    K983406
    Device Name
    SANITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR MERCURY THERMOMETER, SENITHERM ORAL DISPOSABLE THERMOMETER SHEATHS FOR
    Date Cleared
    1998-10-19

    (21 days)

    Product Code
    Regulation Number
    880.2910
    Why did this record match?
    Applicant Name (Manufacturer) :

    BANTA HEALTHCARE GROUP, LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    These devices are indicated for use as a barrier that is used as an accessory to oral or rectal, digital or mercury thermometers. These sheaths are non-sterile and are intended for single patient use only.
    Device Description
    SaniTherm Disposable Thermometer Sheaths are plastic coverings used for either oral or rectal, mercury or digital thermometers. Digital Thermometer Sheaths may not be suitable for use with all clinical thermometers. Example - Clinical thermometers which employ rigid plastic sheaths. Banta Thermometer Sheaths are made from ethylene methyl acrylate copolymer film.
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