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510(k) Data Aggregation

    K Number
    K222801
    Device Name
    Safety Lancet
    Date Cleared
    2023-01-25

    (131 days)

    Product Code
    Regulation Number
    878.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Sarstedt AG **& CO KG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Safety-Lancets with safety feature are used for single use capillary blood sampling.
    Device Description
    The Safety Lancet consists of the following components: colorless plastic body, needle holder with needle or blade shaped lancing device, protective cap, carrier device, two springs, and the release button. The release button, the needle holder, and the protective cap are colored according to the variant available. The lancets are offered with different needle or blade shaped lancing devices, different sharpening and penetration depths, and accordingly in different colors. The lancets contain a safety feature. After puncture the needle retracts automatically into the housing to prevent sharps injuries.
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