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510(k) Data Aggregation

    K Number
    K223480
    Device Name
    Medipoint Blood Lancets
    Date Cleared
    2023-01-13

    (56 days)

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

    Medipoint Holdings, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Medipoint Blood Lancets are indicated to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood.
    Device Description
    Medipoint Blood Lancets are indicated to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood. Medipoint Blood Lancets are single-use only and are discarded into a sharps container immediately after use. The Medipoint Blood Lancet is constructed from a single piece of stainless steel with a sharp, beveled tip for piercing the skin and a knurled grip for maintaining a secure grip on the lancet. Each Medipoint Blood Lancet is individually packaged in a paper package and sterilized in the package via a validated moist heat sterilization process.
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