BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Eagle Electrode Manufacturing Self Adhering Electrodes

    DI: 00867991000200 · Model: EEM2X2S · EAGLE ELECTRODE MANUFACTURING LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Eagle Electrode Manufacturing Self Adhering Electrodes
    Primary DI
    00867991000200
    Version / Model
    EEM2X2S
    Catalog Number
    EEM2X2S
    Company Name
    EAGLE ELECTRODE MANUFACTURING LLC
    Labeler DUNS
    071834627
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-19
    Public Version
    4
    Public Version Date
    2021-02-19
    Public Version Status
    Update
    Public Device Record Key
    06eb4a1a-0425-47d6-a6dd-ec22388716ca

    Device Description

    2 inch square electrodes for use with TENS, NMES, IFC, EMG devices

    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
    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
    Primary 00867991000200

    Customer Contacts

    Phone
    866-486-3332
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K030800 000