BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CoolSeal Trinity

    Reg #: 3010377594 · FEI: 3010377594 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    3
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    BOLDER SURGICAL, LLC
    Registration Number
    3010377594
    FEI Number
    3010377594
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    331 S. 104th Street, Suite 200
    City
    LOUISVILLE
    State
    CO
    ZIP
    80027
    Country
    US

    Regulatory Submissions

    510(k) Number
    K202114

    Owner / Operator

    Firm Name
    Bolder Surgical
    Operator Number
    10044568
    Address
    331 South 104th Street, Suite 200
    City
    Louisville
    State
    CO
    Postal Code
    80027
    Country
    US
    Correspondent
    Nick Wong

    Products

    Device Name Product Code
    Electrosurgical, Cutting & Coagulation & Accessories GEI

    Proprietary Names

    CoolSeal Trinity CoolSeal Mini CoolSeal Generator

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility