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510(k) Data Aggregation

    K Number
    K151182
    Device Name
    LiquiBand Exceed
    Manufacturer
    ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD
    Date Cleared
    2015-10-26

    (175 days)

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

    ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LiquiBand Exceed 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 Exceed topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
    Device Description
    LiquiBand Exceed topical skin adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-Octyl-cyanoacrylate) formulation and the colorant D&C Violet #2. It is provided in a single patient use applicator and packaged in a pouch. The LiquiBand Exceed topical skin adhesive product is comprised of a crushable glass ampoule contained within a plastic applicator with attached foam applicator tip. LiquiBand Exceed topical skin adhesive remains liquid until it is applied to the skin. Upon application LiquiBand Exceed topical skin adhesive polymerizes within minutes.
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    K Number
    K133443
    Device Name
    MARATHON NO STING LIQUID SKIN PROTECTANT
    Manufacturer
    ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD
    Date Cleared
    2014-07-10

    (240 days)

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

    ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Marathon No Sting Liquid Skin Protectant is intended to protect intact or damaged skin from the effects of moisture, friction, (rubbing) or shear (tearing). Marathon No Sting Liquid Skin Protectant helps protect skin exposed to irritation from moisture such as urine, faeces, digestive juices, perspiration and wound drainage. Marathon No Sting Liquid Skin Protectant can also be used in areas that are exposed to friction and shear from bedding, clothing, shoes, or any material that will rub against the skin. Marathon No Sting Liquid Skin Protectant helps protect the skin against irritation caused by adhesive products.
    Device Description
    Not Found
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    K Number
    K132243
    Device Name
    BARLE TISSUE ADHESIVE 2
    Manufacturer
    ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD
    Date Cleared
    2013-12-20

    (155 days)

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

    ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Barle Tissue Adhesive 2 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. Barle Tissue Adhesive 2 topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
    Device Description
    Barle Tissue Adhesive 2 is a sterile, topical tissue adhesive containing 2-octyl cyanoacrylate for wound closure. It is applied to easily approximated skin edges and polymerizes within minutes. Barle Tissue Adhesive 2 is supplied in a single patient use configuration.
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    K Number
    K123133
    Device Name
    BARLE TISSUE ADHESIVE
    Manufacturer
    ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD
    Date Cleared
    2013-05-22

    (230 days)

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

    ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Barle Tissue Adhesive 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. Barle Tissue Adhesive topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
    Device Description
    Barle Tissue Adhesive is a sterile, topical tissue adhesive containing 2-octyl cyanoacrylate for wound closure. Barle Tissue Adhesive 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 minutes. The device is contained within a PET/tyvek blister.
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    K Number
    K122446
    Device Name
    LIQUIDBAND FLOW CONTROL
    Manufacturer
    ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD
    Date Cleared
    2012-10-26

    (77 days)

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

    ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD

    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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