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    FDA UDI In Commercial Distribution 🇺🇸 United States

    SpF XL IIb Implantable Spinal Fusion Stimulator

    DI: 00812301020089 · Model: 10-1335M · EBI, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SpF XL IIb Implantable Spinal Fusion Stimulator
    Primary DI
    00812301020089
    Version / Model
    10-1335M
    Catalog Number
    10-1335M
    Company Name
    EBI, LLC
    Labeler DUNS
    050410323
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2014-09-19
    Public Version
    4
    Public Version Date
    2022-03-10
    Public Version Status
    Update
    Public Device Record Key
    66b0493a-bb74-47fb-866e-0a8855ba558f

    Device Description

    SPF-XL IIB 2/DM

    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
    MR Conditional
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    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
    LOE Stimulator, Invasive Bone Growth

    GMDN Terms

    Code Name
    35463 Patient-worn bone growth electromagnetic stimulator

    Identifiers

    Type ID
    Primary 00812301020089

    Customer Contacts

    Phone
    1.973.299.9300
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    P850035 032