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510(k) Data Aggregation

    K Number
    K140389
    Device Name
    CHLORADERM ANTIMICROBIAL TRANSPARENT THIN FILM DRESSING, 2 3/8 X 2 3/4, 4 X 4 3/4
    Manufacturer
    ENTROTECH LIFE SCIENCES INC.
    Date Cleared
    2014-11-07

    (266 days)

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

    ENTROTECH LIFE SCIENCES INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The entrotech life sciences inc. ChloraDerm™ Antimicrobial Transparent Thin Film Dressings are intended to cover and protect a wound caused by percutaneous medical devices such as drains, chest tubes, orthopedic pins, fixtures and wires. ChloraDerm may also be used to cover and secure primary dressings. ChloraDerm inhibits microbial growth within the dressing and prevents external contamination.
    Device Description
    The entrotech life sciences inc. ChloraDerm™ Antimicrobial Transparent Thin Film Dressings ("ChloraDerm") are intended to cover and protect a wound caused by percutaneous medical devices such as drains, chest tubes, orthopedic pins, fixtures and wires. The ChloraDerm may also be used to cover and secure primary dressings. The ChloraDerm inhibits microbial growth within the dressing and prevents external contamination. ChloraDerm consists of a transparent, thin plastic film coated with an acrylic-based pressure sensitive adhesive containing chlorhexidine as an antimicrobial agent. The ChloraDerm dressing is a single-use device, intended to be used for up to 7 davs.
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