BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PN Wearable Accessory L/XL Horizontal

    DI: 00850051034185 · Model: 00-52003 · Curonix LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    PN Wearable Accessory L/XL Horizontal
    Primary DI
    00850051034185
    Version / Model
    00-52003
    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
    38417024-469f-4341-bf7b-646ba6cb8b72

    Device Description

    PNS Wearable Accessory L/XL Horizontal

    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
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    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
    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 00850051034185

    Premarket Submissions

    Submission Number Supplement Number
    K152178 000