BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    WaveWriter Alpha™ Prime 16

    DI: 08714729985068 · Model: SC-1416 · BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    WaveWriter Alpha™ Prime 16
    Primary DI
    08714729985068
    Version / Model
    SC-1416
    Company Name
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Labeler DUNS
    824951958
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-12-28
    Public Version
    2
    Public Version Date
    2021-02-05
    Public Version Status
    Update
    Public Device Record Key
    5c66d0c7-8aea-46d0-8efa-8501a9642688

    Device Description

    Implantable Pulse Generator Kit

    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
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LGW Stimulator, spinal-cord, totally implanted for pain relief

    GMDN Terms

    Code Name
    64970 Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable

    Identifiers

    Type ID
    Primary 08714729985068

    Premarket Submissions

    Submission Number Supplement Number
    P030017 338