BEUDAMED
    FDA Registration Active 🇺🇸 United States

    BOLDER SURGICAL, LLC

    Reg #: 3010377594 · FEI: 3010377594 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    BOLDER SURGICAL, LLC
    Registration Number
    3010377594
    FEI Number
    3010377594
    Status
    Active
    Expiry Year
    2026
    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
    HOLOGIC, INC.
    Operator Number
    9007676
    Address
    250 Campus Drive, --
    City
    Marlborough
    State
    MA
    Postal Code
    01752
    Country
    US
    Correspondent
    Sue Dahlquist

    Products

    Device Name Product Code
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Staple, Implantable GDW
    Stapler, Surgical GAG

    Proprietary Names

    CoolSeal Mini; CoolSeal Generator CoolSeal Reveal JustRight 5mm Reload; JustRight 5mm Stapler CoolSeal Trinity

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility