BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    C2 CryoBalloon Ablation System

    DI: 00854924006255 · Model: FG-1025 · PENTAX OF AMERICA, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    C2 CryoBalloon Ablation System
    Primary DI
    00854924006255
    Version / Model
    FG-1025
    Company Name
    PENTAX OF AMERICA, INC.
    Labeler DUNS
    083211284
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-04-04
    Public Version
    1
    Public Version Date
    2025-04-14
    Public Version Status
    New
    Public Device Record Key
    4dfcf616-df97-4ff4-b353-81041ee9df86

    Device Description

    Gen 2 360 Degree Pear Catheter

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    GEH Unit, Cryosurgical, Accessories

    GMDN Terms

    Code Name
    45712 Gastrointestinal/biliary dilation balloon catheter, non-medicated

    Identifiers

    Type ID
    Primary 00854924006255