BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GYN-LAP-33B

    Reg #: 3005350457 · FEI: 3005350457 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    21
    Establishment Types
    2
    Classifications
    1

    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
    K081939

    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
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    GYN-LAP-33B BeamPath OTO Handpiece GYN-HP-46 FlexGuide Ultra Tray Lower Genital Procedure Tray ENT Handpiece Set BeamPath Neuro Handpiece Straight Elevate ENT Instrumentation Tray Laparoscopic Handpiece BeamPath Robotic Fiber Conduit BeamPath Neuro Handpiece Bayonet Elevate ENT Handpiece GYN-HP-29 FlexGuide Ultra Robotic Fiber Conduit Lower Genital Handpiece BeamPath OTO Handpiece Set ENT Handpiece ENT Handpiece Tray Laparoscopic Procedure Tray BeamPath CO2 Laser Fiber Surgical Handpiece BeamPath Neuro Handpiece Set

    Establishment Types

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