BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Evoke® Clinical Interface (CI)

    DI: 09352307001183 · Model: 3024 · SALUDA MEDICAL PTY LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Evoke® Clinical Interface (CI)
    Primary DI
    09352307001183
    Version / Model
    3024
    Catalog Number
    3024
    Company Name
    SALUDA MEDICAL PTY LIMITED
    Labeler DUNS
    744596461
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-11-29
    Public Version
    3
    Public Version Date
    2023-10-09
    Public Version Status
    Update
    Public Device Record Key
    97862232-9142-44f7-a28f-4ce0ff8def0e

    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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    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
    60363 Implantable electrical stimulation device management software

    Identifiers

    Type ID
    Primary 09352307001183

    Premarket Submissions

    Submission Number Supplement Number
    P190002 011

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 60 Degrees Celsius
    Type
    Handling Environment Temperature
    Temperature Range
    -20 – 60 Degrees Celsius