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510(k) Data Aggregation

    K Number
    K963188
    Device Name
    DRAIN/SLIT SPONGE (NON-STERILE AND STERILE)
    Date Cleared
    1996-10-30

    (76 days)

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

    CODI INTERNATIONAL BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    It is intended that the drain/slit sponges will be used as a dressing around tubes and needles and for other general medical and dental purposes for which cotton gauze has traditionally been used.
    Device Description
    The products to be manufactured by CODI International BV are non-sterile and sterile versions of a nonwoven synthetic drain/slit sponge that is substantially equivalent to the general use sponges currently produced by CODI International BV for multiple private labels. The drain/slit sponges do not have a different intended use or different technological characteristics than the general use sponges, except that the drain/slit sponges have a slit cut in them to accommodate a tube or needle. The drain/slit sponges are made of rayon and polyester fibers and will be sterilized by radiation or ethylene oxide methods. The finished products have a pattern similar to traditional cotton gauze, but they are softer and more absorbent. The CODI products also have minimal linting and wound adhesion compared to traditional cotton gauze.
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    K Number
    K961061
    Device Name
    CODI SYNTHETIC SPONGE(NON-STERILE AND STERILE)
    Date Cleared
    1996-06-06

    (80 days)

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

    CODI INTERNATIONAL BV

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    It is intended that the CODI products will be used as a dressing and for other general medical and dental purposes for which cotton gauze has traditionally been used.
    Device Description
    The products to be manufactured by CODI International BV are non-sterile and sterile versions of a nonwoven synthetic sponge that is substantially equivalent to the product currently marketed by Johnson & Johnson Medical, Inc. and known as Nu Gauze and the product currently marketed by Kendall Co. and known as Versalon. The CODI products do not have a different intended use or different technological characteristics than Johnson's Nu Gauze or Kendall's Versalon. The CODI products are made of rayon and polyester fibers and will be sterilized by radiation or ethylene oxide methods. The finished products have a pattern similar to traditional cotton gauze, but they are softer and more absorbent. The CODI products also have minimal linting and wound adhesion compared to traditional cotton gauze.
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