BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Rochester

    DI: 00849593025409 · Model: NC-853025 · Advantage Medical Electronics, LLC
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Rochester
    Primary DI
    00849593025409
    Version / Model
    NC-853025
    Company Name
    Advantage Medical Electronics, LLC
    Labeler DUNS
    080242300
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-02-08
    Public Version
    1
    Public Version Date
    2023-02-16
    Public Version Status
    New
    Public Device Record Key
    46fdc4e9-4e62-4553-86ce-a7b7600f1ea5

    Device Description

    DISPOSABLE CONCENTRIC NEEDLE ELECTRODE 30 GA, 25MM NEEDLE, RED

    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
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

    Code Name
    GXZ Electrode, Needle
    IKT Electrode, Needle, Diagnostic Electromyograph

    GMDN Terms

    Code Name
    11441 Electromyographic needle electrode, single-use

    Identifiers

    Type ID
    Package 00849593025416
    Primary 00849593025409