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510(k) Data Aggregation

    K Number
    K162352
    Device Name
    derma+flex QS High Viscosity Tissue Adhesive
    Manufacturer
    CHEMENCE MEDICAL INC
    Date Cleared
    2016-12-22

    (121 days)

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

    CHEMENCE MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    derma+flex® QS ™ High Viscosity Tissue Adhesive is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. derma+flex® QS ™ High Viscosity Tissue Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.
    Device Description
    derma+flex® QS™ High Viscosity Tissue 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 use aluminum collapsible tube packaged in a RXM 48gaPET-200LDPE Film/1095B uncoated Tyvek pouch also containing 2 Indothene HD Grade HD50MA 180 applicator tips. The dauber applicator is comprised of a self-puncturing cap and a foam surface, which allows spreading of the adhesive with uniformity. The nozzle applicator is also a self-puncturing cap with an elongation that enables detailed application of the adhesive. As applied to the skin, the liquid is syrup-like in viscosity and polymerizes within minutes. The increased viscosity of derma+flex® QS™ is intended to reduce the risk of unintended placement of the adhesive during application due to migration of the liquid adhesive from the wound site.
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    K Number
    K050757
    Device Name
    FLEX-AID LIQUID GEL BANDAGE AND DERMAFLEX GEL TISSUE ADHESIVE PROFESSIONAL LIQUID BANDAGE
    Manufacturer
    CHEMENCE MEDICAL INC.
    Date Cleared
    2006-02-23

    (337 days)

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

    CHEMENCE MEDICAL INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DERMA+FLEX™ Gel Adhesive is indicated for OTC use to cover minor cuts, scrapes and minor irritations of the skin and help protect them from infection.
    Device Description
    DERMA+FLEX™ Gel Adhesive is a sterile, clear, high viscosity, flexible, liquid topical bandage composed of a blend of 2-Octyl and N-Butyl cyanoacrylate monomers with an octyl cyanoacrylate polymer, tributyl citrate (a plasticizer) and containing D&C violet #2 pigment. DERMA+FLEX™ is supplied in 0.5g single patient use aluminum tubes with (2) self-piercing applicator caps (a dauber cap and a nozzle cap). Each sterile single use aluminum tube is packaged with applicators in individual Tyvek pouches and sterilized by EtO sterilization rendering the exterior of the tube and applicators suitable for dispensing on sterile fields.
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