BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Battery Charger

    DI: 00818225020891 · Model: MD0567-R1 · STIMWAVE TECHNOLOGIES INCORPORATED
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Battery Charger
    Primary DI
    00818225020891
    Version / Model
    MD0567-R1
    Company Name
    STIMWAVE TECHNOLOGIES INCORPORATED
    Labeler DUNS
    078294927
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-02-05
    Public Version
    4
    Public Version Date
    2020-02-06
    Public Version Status
    Update
    Public Device Record Key
    d54476ab-613a-412e-898e-f07487e77c02

    Device Description

    Freedom Spinal Cord Stimulator System/StimQ Peripheral Nerve Stimulator System Battery Charger

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Unsafe
    Direct Marking Exempt
    Yes
    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
    GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief)
    GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)

    GMDN Terms

    Code Name
    17115 Noninvasive device battery charger

    Identifiers

    Type ID
    Primary 00818225020891

    Premarket Submissions

    Submission Number Supplement Number
    K170141 000
    K171366 000