BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TEMNO Elite™

    DI: 00884450397824 · Model: 00884450397824 · Merit Medical Systems, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TEMNO Elite™
    Primary DI
    00884450397824
    Version / Model
    00884450397824
    Catalog Number
    TE1610
    Company Name
    Merit Medical Systems, Inc.
    Labeler DUNS
    184763290
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-04-08
    Public Version
    1
    Public Version Date
    2023-04-17
    Public Version Status
    New
    Public Device Record Key
    7fd0c7ad-b9ef-4f19-bba3-773715c539be

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KNW INSTRUMENT, BIOPSY

    GMDN Terms

    Code Name
    16835 Soft-tissue biopsy procedure kit, non-medicated

    Identifiers

    Type ID
    Package 10884450397821
    Primary 00884450397824
    Package 20884450397828

    Device Sizes

    Type Value Unit Text
    Device Size Text, specify Biopsy Device Length (cm)-10.0 cm
    Device Size Text, specify Biopsy Device Gauge-16G