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510(k) Data Aggregation

    K Number
    K190161
    Device Name
    Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray
    Manufacturer
    Gebauer Company
    Date Cleared
    2019-05-07

    (97 days)

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

    Gebauer Company

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Gebauer's Ethyl Chloride Topical Anesthetic Spray (Mist Spray, Fine Spray and Medium Spray): A vapocoolant (skin refrigerant) intended for topical application to control pain associated with injections (starting IV's and venipuncture), minor surgical procedures (such as lancing boils, or incision and drainage of small abscesses), and the temporary relief of minor sports injuries. The Fine and Medium Sprays are also intended for the treatment of myofascial pain caused by trigger points, restricted motion and muscle tension.
    Device Description
    Gebauer's Ethyl Chloride Topical Anesthetic Spray is a prescription device designed to deliver ethyl chloride in a mist, fine or medium spray. This chemical self-propels itself from the delivery system, which is designed to account for its low vapor pressure. The device is packaged in either a pharmaceutical glass bottle or steel aerosol can with several variations of nozzles. The patient contact is less than ten seconds and the skin is cooled through rapid evaporation of the non-medicated volatile propellant.
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    K Number
    K172028
    Device Name
    Gebauer’s Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray)
    Manufacturer
    Gebauer Company
    Date Cleared
    2017-10-27

    (114 days)

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

    Gebauer Company

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Gebauer's Pain Ease Topical Anesthetic Skin Refrigerant (Mist Spray and Medium Spray): a vapocoolant (skin refrigerant) intended for topical application to skin, mucous membranes and minor open wounds. Gebauer's Pain Ease controls pain associated with minor surgical procedures (such as lancing boils, incisions, drainage of small abscesses, and sutures), injections (venipuncture, IV starts, cosmetic procedures) and the temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions). The Medium Spray is also intended for the treatment of myofascial pain caused by trigger points, restricted motion and muscle tension.
    Device Description
    Gebauer's Pain Ease (Mist and Medium Spray) Topical Anesthetic Skin Refrigerant is a prescription device designed to deliver HFC 245fa high purity (1,1,1,3,3-Pentafluoropropane) and HFC 134a pharmaceutical grade (1,1,1,2-Tetrafluoroethane) in a mist and medium spray. This mixture self-propels itself from the delivery system. which is designed to account for its low vapor pressure. The device delivery system is specifically designed to deliver a medium and mist spray of the Gebauer's Pain Ease (Mist Spray and Stream Spray) mixture. The medium and mist spray is an appropriate mode of application when users follow directions for use, cooling the skin through rapid evaporation of the non-medicated volatile propellants. The new device, Gebauer's Pain Ease, is identical in all aspects to the predicate device, Gebauer's Pain Ease (Mist Spray and Medium Spray) 510(k) K032671, except that the product can be applied to the skin for pre-injection anesthesia by cotton swab or gauze on intact skin. (If the skin is breached use this application method only with STERILE, disposable cotton balls, cotton swabs or gauze. The cotton balls, cotton swabs or gauze are not supplied with the device.)
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