BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    Horizon™

    DI: 10816843021983 · Model: S83021-R10 · ROCHESTER ELECTRO-MEDICAL, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Horizon™
    Primary DI
    10816843021983
    Version / Model
    S83021-R10
    Company Name
    ROCHESTER ELECTRO-MEDICAL, INC.
    Labeler DUNS
    068156330
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    3
    Public Version Date
    2019-05-21
    Public Version Status
    Update
    Public Device Record Key
    8da47f84-1075-4418-95c8-59065e3e6a32
    Distribution End Date
    2019-05-20

    Device Description

    DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 13 MM NEEDLE, 21" RIBBON LEADWIRE (3-LEAD), COLOR GROUP R10

    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
    Yes
    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
    No

    Product Codes

    Code Name
    GXZ Electrode, Needle

    GMDN Terms

    Code Name
    47714 Subdermal needle electrode

    Identifiers

    Type ID
    Primary 10816843021983

    Customer Contacts

    Phone
    18003285544
    Email
    [email protected]