BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    LUNA XD

    DI: 00840606164276 · Model: LUN4001 · SPINAL ELEMENTS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    LUNA XD
    Primary DI
    00840606164276
    Version / Model
    LUN4001
    Company Name
    SPINAL ELEMENTS, INC.
    Labeler DUNS
    610712213
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-11-30
    Public Version
    1
    Public Version Date
    2022-12-08
    Public Version Status
    New
    Public Device Record Key
    df5fdf66-7970-4c38-87c1-7188274b576f

    Device Description

    Luna Graft Injector Tool, Disposable

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MAX Intervertebral Fusion Device With Bone Graft, Lumbar

    GMDN Terms

    Code Name
    46119 Bone graft delivery kit

    Identifiers

    Type ID
    Primary 00840606164276