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510(k) Data Aggregation

    K Number
    K050320
    Device Name
    FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT
    Date Cleared
    2005-08-15

    (187 days)

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

    ASCENDIA MEDTECH AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The FreeeScan® Ultrasound Transducer Covers are protective covers applied to ultrasound transducers. These covers are designed to provide a sterile barrier between the non-sterile TXD's (and instrument guide adapters in some cases) and the patient/healthcare worker. The covers are intended for use during both sterile and non-sterile procedures using sector, linear, intravaginal and rectal transducers. The cover is latex-free and therefore beneficial in procedures with a patient with known type I hypersensitivity, or for the healthcare worker who has become type I sensitive. The transducer covers are supplied sterile or non-sterile and intended for single-use. Covers are packed in sterile or non-sterile "convenience" kits form for single patient/procedure, disposable use. Covers kits are supplied with needle guide devices, coupling gel packet, elastic bands, and tape.
    Device Description
    The FreeeScan® Ultrasound Transducer Cover provides a thin, conformal covering to fit various ultrasound transducer geometries. The device is manufactured as a one-piece design that provides a covering to prevent the transmission of pathogens, as the ultrasound transducer is reused from one patient to another. The cover material is Chloroprene (synthetic rubber), which is similar to the non-latex material used in medical examination gloves or surgical gloves. Type I natural latex allergy does not occur in response to Chloroprene since the synthetic rubber does not contain the natural protein allergen which is present in latex. Various sizes and shapes of covers are offered in order to fit different transducer geometries. The following product models are currently included (other shapes are likely to be added): - . FreeeScan® 1 - W:3.4 cm, L:45-244 cm (Drawing 5500-000002-1B) - FreeeScan® 4 W:10 cm, L:45-244 cm (Drawing 5500-000003-1B) . - FreeeScan® 6 W:9.5/11.5 cm, L:45-244 cm (Drawing 5500-000004-1B) . - . FreeeScan® 8 - W:7.5 cm, L:45-244 cm (Drawing 5500-000005-1B) - FreeeScan® 77 Ø:2.6 cm, L:30 cm (Drawing 5500-000016-1A) . - FreeeScan® 84 Ø:3 cm, L:30 cm (Drawing 5500-000015-1A) . All of these versions are composed of the same materials, they are made using the same processes and procedures, in the same facilities and on the same equipment.
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