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510(k) Data Aggregation

    K Number
    K110184
    Device Name
    LIQUIBAND FLOW CONTROL
    Manufacturer
    MEDLOGIC GLOBAL LIMITED
    Date Cleared
    2011-12-16

    (329 days)

    Product Code
    MPN
    Regulation Number
    878.4010
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDLOGIC GLOBAL LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LiquiBand Flow Control topical skin adhesive is intended for topical applications only, to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery and simple, thoroughly cleansed, trauma induced lacerations. LiquiBand Flow Control topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
    Device Description
    LiquiBand® Flow Control is a sterile, topical tissue adhesive containing n-butyl-2-cyanoacrylate for wound closure. LiquiBand® Flow Control is supplied in a single patient use configuration. The applicator is composed of a crushable glass ampoule contained within a plastic polypropylene applicator. The ampoule is crushed through force applied by the clinician to the 'wings' of the applicator body. It is applied to easily approximated skin edges and polymerizes within 30 seconds. The device is contained within a PET/tyvek blister
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    K Number
    K102076
    Device Name
    LIQUIBAND DUAL, MODEL LBD 001
    Manufacturer
    MEDLOGIC GLOBAL LIMITED
    Date Cleared
    2011-02-18

    (207 days)

    Product Code
    MPN
    Regulation Number
    878.4010
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDLOGIC GLOBAL LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LiquiBand Dual topical skin adhesive is intended for topical applications only, to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery and simple, thoroughly cleansed, trauma induced lacerations. LiguiBand Dual topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
    Device Description
    LiquiBand® Dual is a sterile, topical tissue adhesive containing n-butyl-2-cyanoacrylate for initial wound closure and a blend of 30% n-butyl-cyanoacrylate and 70% 2-octyl cyanoacrylate for subsequent over layers . LiquiBand® Dual is supplied in a single patient use dual applicator configuration.
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    K Number
    K100284
    Device Name
    LIQUIBAND ULTIMA, LUT 003
    Manufacturer
    MEDLOGIC GLOBAL LIMITED
    Date Cleared
    2010-04-09

    (67 days)

    Product Code
    MPN
    Regulation Number
    878.4010
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDLOGIC GLOBAL LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LiquiBand Ultima topical skin adhesive is intended for topical applications only, to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery and simple, thoroughly cleansed, trauma induced lacerations. LiquiBand Ultima topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
    Device Description
    LiquiBand® Ultima is a sterile, topical tissue adhesive containing n-butyl-2-cyanoacrylate. LiquiBand® Ultima is supplied in a single patient use dual tip configuration.
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    K Number
    K031321
    Device Name
    LIQUISHIELD LIQUID BANDAGE, MODEL LSB 0001
    Manufacturer
    MEDLOGIC GLOBAL LIMITED
    Date Cleared
    2004-01-21

    (271 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDLOGIC GLOBAL LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LiquiShield™ Liquid Bandage is intended for over the counter (OTC) use to cover minor cuts and scrapes and minor irritations of the skin and help protect them from infection.
    Device Description
    LiquiShield™ Liquid Bandage biocompatible cyanoacrylate-based, drying, liquid barrier film for the protection the skin. It is applied as a liquid and dries, within approximately 45 seconds, adhering to the contours of the skin to form a transparent, flexible film. LiquiShield™ Liquid Bandage wears off naturally as the skin regenerates. The applicator and contents are supplied sterile, and the device is, therefore, suitable for aseptic techniques.
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    K Number
    K023163
    Device Name
    LIQUISHIELD-S (0.7G), MODEL LS 0010, LIQUISHIELD-S (2.0G), MODEL LS 0020
    Manufacturer
    MEDLOGIC GLOBAL LIMITED
    Date Cleared
    2003-01-13

    (112 days)

    Product Code
    KMF
    Regulation Number
    880.5090
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDLOGIC GLOBAL LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LiquiShield®-S is intended to protect intact or damaged skin from the effects of moisture, friction (rubbing), or shear (tearing). LiquiShield®-S helps protect skin exposed to irritation from moisture such as urine, faeces, digestive juices, perspiration and wound drainage. LiquiShield®-S can also be used in areas that are exposed to friction and shear such as occurs when items, such as bedding, clothing, or shoes, rub against the skin. LiquiShield®-S helps protect the skin against irritation caused by adhesive products.
    Device Description
    LiquiShield®-S is a non-cytotoxic (not harmful to the bodv) cyanoacrylate based, rapid drying, liquid barrier film for the protection of the skin. It is applied as a liquid and dries, within 45 seconds, adhering to the contours of the skin to form a transparent flexible film. LiquiShield®-S will wear off, naturally, as the skin regenerates. The applicator and packaging are sterilized.
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