BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    One +Step

    DI: 06949517008847 · Model: LF-TL-23-I · Shandong Lianfa Medical Plastic Products CO.,LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    50

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    Basic Information

    Brand Name
    One +Step
    Primary DI
    06949517008847
    Version / Model
    LF-TL-23-I
    Company Name
    Shandong Lianfa Medical Plastic Products CO.,LTD
    Labeler DUNS
    421330121
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    50
    Record Status
    Published
    Publish Date
    2025-06-27
    Public Version
    1
    Public Version Date
    2025-07-07
    Public Version Status
    New
    Public Device Record Key
    c4b5a5b9-88a8-4534-a7b7-5a6e3d90bae5

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    QRL Multiple Use Blood Lancet For Single Patient Use Only

    GMDN Terms

    Code Name
    61579 Blood lancet, single-use

    Identifiers

    Type ID
    Unit of Use 56949517070894
    Primary 06949517008847

    Premarket Submissions

    Submission Number Supplement Number
    K222472 000