BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TestWell Choice 21G Safety Lancet

    DI: 10743820218169 · Model: 21816 · Boca Med, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    16

    Basic Information

    Brand Name
    TestWell Choice 21G Safety Lancet
    Primary DI
    10743820218169
    Version / Model
    21816
    Company Name
    Boca Med, LLC
    Labeler DUNS
    121164730
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    16
    Record Status
    Published
    Publish Date
    2023-02-07
    Public Version
    2
    Public Version Date
    2023-02-22
    Public Version Status
    Update
    Public Device Record Key
    d12d5acb-affb-4183-8db9-5d4a6219f5a7

    Device Description

    TestWell Choice 21G Safety Lancet NDC Number: 08326-2118-16

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    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
    FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

    GMDN Terms

    Code Name
    61578 Manual blood lancing device, single-use

    Identifiers

    Type ID
    Primary 10743820218169
    Unit of Use 00743820218162
    Package 30743820218163