BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    INCORPORATE

    DI: 00840916126384 · Model: 104-2-17144010 · SPINAL ELEMENTS
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    INCORPORATE
    Primary DI
    00840916126384
    Version / Model
    104-2-17144010
    Company Name
    SPINAL ELEMENTS
    Labeler DUNS
    004022104
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-03-22
    Public Version
    4
    Public Version Date
    2020-12-18
    Public Version Status
    Update
    Public Device Record Key
    b1ffe817-6e12-4391-8c00-f3acc417ee4c

    Device Description

    INCORPORATE® 17MM X 14MM X 40MM 10° L VBR IMPLANT

    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
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MQP Spinal Vertebral Body Replacement Device

    GMDN Terms

    Code Name
    60762 Polymeric spinal interbody fusion cage

    Identifiers

    Type ID
    Primary 00840916126384