BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    SCS Freedom-4A Permanent Neurostimulator Receiver Kit Channel A

    DI: 00850051034017 · Model: FR4A-RCV-A0 · Curonix LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    SCS Freedom-4A Permanent Neurostimulator Receiver Kit Channel A
    Primary DI
    00850051034017
    Version / Model
    FR4A-RCV-A0
    Company Name
    Curonix LLC
    Labeler DUNS
    118972620
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-04-06
    Public Version
    1
    Public Version Date
    2023-04-14
    Public Version Status
    New
    Public Device Record Key
    eb9beb53-2d69-4bb6-82e6-4666cc056e12

    Device Description

    SCS Freedom-4A Permanent Neurostimulator Receiver Kit Channel A

    Device Characteristics

    Single Use
    Yes
    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 Conditional
    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)

    GMDN Terms

    Code Name
    64970 Spinal cord/peripheral nerve implantable analgesic electrical stimulation system pulse generator, implantable

    Identifiers

    Type ID
    Primary 00850051034017

    Premarket Submissions

    Submission Number Supplement Number
    K182720 000