BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Senza

    DI: 00813426020664 · Model: EXTS3000 · NEVRO CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Senza
    Primary DI
    00813426020664
    Version / Model
    EXTS3000
    Catalog Number
    EXTS3000
    Company Name
    NEVRO CORP.
    Labeler DUNS
    926599155
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-03-24
    Public Version
    2
    Public Version Date
    2021-07-08
    Public Version Status
    Update
    Public Device Record Key
    f5d1e4b4-fc3c-4257-9fcf-51f6c0186e60

    Device Description

    Bluetooth Trial stimulator kit

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Unsafe
    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
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LGW Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

    GMDN Terms

    Code Name
    61472 Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system pulse generator

    Identifiers

    Type ID
    Primary 00813426020664

    Customer Contacts

    Phone
    6502510005
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    P130022 000