BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Freedom System Accessories

    DI: 00850051034253 · Model: MD0725-12-SS · Curonix LLC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Freedom System Accessories
    Primary DI
    00850051034253
    Version / Model
    MD0725-12-SS
    Company Name
    Curonix LLC
    Labeler DUNS
    118972620
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-04-07
    Public Version
    1
    Public Version Date
    2023-04-17
    Public Version Status
    New
    Public Device Record Key
    955a1a0b-7cca-45d1-9805-d9536376c74b

    Device Description

    Antenna 12" Length

    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
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    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
    GZB Stimulator, Spinal-Cord, Implanted (Pain Relief)
    GZF Stimulator, Peripheral Nerve, Implanted (Pain Relief)

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 00850051034253

    Premarket Submissions

    Submission Number Supplement Number
    K152178 000
    K182720 000