BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TRIO Handpiece

    Reg #: 3005350457 · FEI: 3005350457 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    Omni-Guide Holdings, Inc.
    Registration Number
    3005350457
    FEI Number
    3005350457
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    43 Manning Road
    City
    Billerica
    State
    MA
    ZIP
    01821
    Country
    US

    Regulatory Submissions

    510(k) Number
    K183199

    Owner / Operator

    Firm Name
    OMNIGUIDE, INC.
    Operator Number
    9070939
    Address
    43 Manning Rd
    City
    Billerica
    State
    MA
    Postal Code
    01821
    Country
    US
    Correspondent
    Carlos O Acosta

    Products

    Device Name Product Code
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    TRIO Handpiece

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility