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510(k) Data Aggregation

    K Number
    K151070
    Device Name
    Sonishield 100 Antimicrobial Ultrasound Gel
    Manufacturer
    Quotient Medical
    Date Cleared
    2016-01-13

    (267 days)

    Product Code
    MUI
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Quotient Medical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sonishield™ 100 Antimicrobial Ultrasound Gel is intended for general use as a non-sterile transmission media for acoustically coupling a transducer to a human body surface during external and therapeutic ultrasound imaging procedures. It is placed on the patient's skin prior to initiating an ultrasound examination. It is indicated for prescription use only.
    Device Description
    Sonishield™ 100 Antimicrobial Ultrasound Gel consists of deionized water, hydroxyethylcellulose, propanediol and benzalkonium chloride. It is a type of conductive medium (i.e.) scanning gel used in ultrasound therapeutic and diagnostic imaging techniques. A scanning gel acts as a couplant that provides an acoustic pathway between the transducer and the skin. In addition, the gel eliminates air (a disruptive influence) from the interface and adapts the contours of the probe to the skin. The major characteristics of Sonishield™ 100 Antimicrobial Ultrasound Gel include: - Hypoallergenic, non-irritating - Water soluble, non-staining and easily cleanable - . Does not contain oil or fatty matter - Free from formaldehyde and salt ● - No toxic effects - Produced as a completely harmless material - Has no odor - Vacuum treated production - Does not damage the probe - Does not contain air bubbles - pH level ranges from 4.5 to 6.5 at 25°C ●
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