BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Evoke® External Closed-Loop Stimulator (eCLS)

    DI: 09352307000346 · Model: 3036 · SALUDA MEDICAL PTY LIMITED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Evoke® External Closed-Loop Stimulator (eCLS)
    Primary DI
    09352307000346
    Version / Model
    3036
    Catalog Number
    3036
    Company Name
    SALUDA MEDICAL PTY LIMITED
    Labeler DUNS
    744596461
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-03-15
    Public Version
    2
    Public Version Date
    2023-10-09
    Public Version Status
    Update
    Public Device Record Key
    371e5c6f-6cbc-43a9-b68b-4fcc7077552c

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

    Identifiers

    Type ID
    Primary 09352307000346

    Premarket Submissions

    Submission Number Supplement Number
    P190002 000

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    -10 – 55 Degrees Celsius
    Type
    Storage Environment Temperature
    Temperature Range
    -10 – 55 Degrees Celsius