BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OptiMap™Catheter Extension Cable

    DI: 00850064686081 · Model: FG0004 · Cortex, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OptiMap™Catheter Extension Cable
    Primary DI
    00850064686081
    Version / Model
    FG0004
    Catalog Number
    OPTI-CEC
    Company Name
    Cortex, Inc.
    Labeler DUNS
    119228234
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-07-24
    Public Version
    1
    Public Version Date
    2025-08-01
    Public Version Status
    New
    Public Device Record Key
    795914a5-5add-4126-8c6b-807dfb1b76d9

    Device Description

    OptiMap™ Catheter Extension Cable

    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
    Yes
    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
    Yes
    Sterilization Methods
    Ethylene Oxide

    Product Codes

    Code Name
    IKD Cable, Electrode

    GMDN Terms

    Code Name
    46429 Electrical-only medical device connection cable, reprocessed

    Identifiers

    Type ID
    Primary 00850064686081