BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Coagulation RF cable

    DI: 10840143901485 · Model: CSK-2060 · ATRICURE, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Coagulation RF cable
    Primary DI
    10840143901485
    Version / Model
    CSK-2060
    Catalog Number
    A001184
    Company Name
    ATRICURE, INC.
    Labeler DUNS
    006133784
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-09-23
    Public Version
    1
    Public Version Date
    2022-10-03
    Public Version Status
    New
    Public Device Record Key
    881d02b4-a87b-47d9-ab69-7378a5982fab

    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
    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
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OCM Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation

    GMDN Terms

    Code Name
    60784 Cardiac radio-frequency ablation system generator

    Identifiers

    Type ID
    Package 30840143901663
    Primary 10840143901485
    Package 50840143902442

    Customer Contacts

    Phone
    866-449-2342
    Email
    [email protected]

    Storage Conditions

    Type
    Handling Environment Humidity
    Temperature Range
    30 – 85 Percent (%) Relative Humidity
    Type
    Handling Environment Temperature
    Temperature Range
    -20 – 60 Degrees Celsius