BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    mySCS™ GO

    DI: 00191506020705 · Model: SC-5275 · BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    mySCS™ GO
    Primary DI
    00191506020705
    Version / Model
    SC-5275
    Company Name
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Labeler DUNS
    824951958
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-04-22
    Public Version
    1
    Public Version Date
    2024-04-30
    Public Version Status
    New
    Public Device Record Key
    9b3b3590-5939-486b-94d5-bc8abe7b081b

    Device Description

    Therapy Controller App

    Device Characteristics

    Single Use
    No
    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
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    QRB Stimulator, spinal-cord, totally implanted for relief of pain due to diabetic neuropathy
    LGW Stimulator, spinal-cord, totally implanted for pain relief

    GMDN Terms

    Code Name
    61588 Implantable spinal cord electrical stimulation system programmer

    Identifiers

    Type ID
    Primary 00191506020705

    Premarket Submissions

    Submission Number Supplement Number
    P030017 357
    P030017 358
    P030017 363