BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OptiMap Catheter - 50mm

    DI: 00850064686159 · Model: OPTI-CATH2-50 · Cortex, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OptiMap Catheter - 50mm
    Primary DI
    00850064686159
    Version / Model
    OPTI-CATH2-50
    Company Name
    Cortex, Inc.
    Labeler DUNS
    119228234
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2026-04-02
    Public Version
    1
    Public Version Date
    2026-04-10
    Public Version Status
    New
    Public Device Record Key
    29db0141-20c0-4c01-a49f-979ea6169dbe

    Device Description

    Generation 2 OptiMap catheter, 50 mm diameter

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MTD Catheter, Intracardiac Mapping, High-Density Array

    GMDN Terms

    Code Name
    46355 Cardiac mapping catheter, percutaneous, single-use

    Identifiers

    Type ID
    Primary 00850064686159

    Storage Conditions

    Type
    Handling Environment Humidity
    Temperature Range
    – 85 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    2 – 25 Degrees Celsius
    Type
    Handling Environment Temperature
    Temperature Range
    -29 – 60 Degrees Celsius