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    FDA UDI In Commercial Distribution 🇺🇸 United States

    AcuZone

    DI: 06959006303322 · Model: AcuZone-44-2x2 pigtail electrodes · CATHAY MANUFACTURING CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    11

    Basic Information

    Brand Name
    AcuZone
    Primary DI
    06959006303322
    Version / Model
    AcuZone-44-2x2 pigtail electrodes
    Company Name
    CATHAY MANUFACTURING CORP.
    Labeler DUNS
    421287342
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    11
    Record Status
    Published
    Publish Date
    2020-11-13
    Public Version
    2
    Public Version Date
    2021-02-19
    Public Version Status
    Update
    Public Device Record Key
    39c49856-9ce7-4032-ab62-70c08a7a4290
    Distribution End Date
    2025-11-12

    Device Description

    AcuZone-44-2x2 pigtail electrodes, for TENS EMS

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    Yes
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GXY Electrode, Cutaneous

    GMDN Terms

    Code Name
    35995 Transcutaneous electrical stimulation electrode, single-use

    Identifiers

    Type ID
    Package 16959006303329
    Primary 06959006303322
    Unit of Use 26959006303326