BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OptiMap™ Cable Kit - NA

    DI: 00850064686043 · Model: FG0011-NA · Cortex, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OptiMap™ Cable Kit - NA
    Primary DI
    00850064686043
    Version / Model
    FG0011-NA
    Catalog Number
    OPTI-CAB-NA
    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
    3
    Public Version Date
    2025-10-20
    Public Version Status
    Update
    Public Device Record Key
    7eda8ce4-d701-4d1c-be9e-489ebfca3999

    Device Description

    OptiMap Cable Kit - North American

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DSA Cable, Transducer And Electrode, Patient, (Including Connector)

    GMDN Terms

    Code Name
    47487 Electrical-only medical device connection cable, reusable

    Identifiers

    Type ID
    Primary 00850064686043

    Storage Conditions

    Type
    Storage Environment Humidity
    Temperature Range
    10 – 80 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    0 – 50 Degrees Celsius