BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    On Call Stealth Lancing Device

    DI: 00682607541829 · Model: G124-18A · Acon Laboratories, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    On Call Stealth Lancing Device
    Primary DI
    00682607541829
    Version / Model
    G124-18A
    Catalog Number
    G124-18A
    Company Name
    Acon Laboratories, Inc.
    Labeler DUNS
    781100966
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-02-03
    Public Version
    1
    Public Version Date
    2026-02-11
    Public Version Status
    New
    Public Device Record Key
    5cf17178-7708-45dc-8f6e-92d3e9f7e838

    Device Description

    1 Lancing Device

    Device Characteristics

    Single Use
    No
    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    QRL Multiple use blood lancet for single patient use only

    GMDN Terms

    Code Name
    37243 Manual blood lancing device, reusable

    Identifiers

    Type ID
    Package 20682607541823
    Primary 00682607541829

    Customer Contacts

    Phone
    +1(800)838-9502 ext. 1
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K113332 000