BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Omni-Guide Holdings, Inc.

    Reg #: 3005350457 · FEI: 3005350457 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    56
    Establishment Types
    3
    Classifications
    4

    Registration Details

    Registration Name
    Omni-Guide Holdings, Inc.
    Registration Number
    3005350457
    FEI Number
    3005350457
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    43 Manning Road
    City
    Billerica
    State
    MA
    ZIP
    01821
    Country
    US

    Regulatory Submissions

    510(k) Number
    K141484

    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
    Electrocautery, Gynecologic (And Accessories) HGI
    Powered Laser Surgical Instrument GEX
    Laser, Ophthalmic HQF

    Proprietary Names

    OPEN FMSEALER DOMAIN SURGICAL SYSTEM Gas Filter Unit GYN-HP-29 BeamPath OTO Handpiece Set GYN-HP-46 Lower Genital Procedure Tray FlexGuide Ultra Tray Elevate ENT Instrumentation Tray BeamPath CO2 Laser Fiber Surgical Handpiece BeamPath Robotic Fiber Conduit BeamPath Neuro Handpiece Set BeamPath Neuro Handpiece Straight Laparoscopic Procedure Tray BeamPath Neuro Handpiece Bayonet BeamPath OTO Handpiece ENT Handpiece Tray Elevate ENT Handpiece ENT Handpiece ENT Handpiece Set FlexGuide Ultra Robotic Fiber Conduit GYN-LAP-33B Lower Genital Handpiece Laparoscopic Handpiece FMWAND FERROMAGNETIC SURGICAL SYSTEM Electrosurgical cutting and coagulation device and accessories Intelliguide Laser System Fiber Enabled Laser System C-Las FELS-25A-LS FELS-25A Powered laser surgical instrument FMWAND HANDPIECE SE OmniGuide Laser System with FlexGuide Ultra Powered laser surgical instrument - RevoLix 200 Powered laser surgical instrument - RevoLix Duo OTO-M OTO-S Powered laser surgical instrument - RevoLix Laser OmniGuide PRIMA Surgical Laser Fibers OmniGuide RFID Surgical Laser FIbers TRIO Handpiece BeamPath BP-Robotic Fiber BeamPath GYN-L Fiber BeamPath BP-LE Fiber Elevate Elite ENT Fiber Elevate ENT Fiber BeamPath NEURO-L Fiber BeamPath ENT-L Fiber Velocity™ Fiber Powered laser surgical instrument - Sphinx Jr. GEX/Powered laser surgical instrument Powered laser surgical instrument - RevoLix 120 Laparoscopic FMsealer Laser, ophthalmic Beacon Advanced Energy Laser System LISA Laser Surgical Fibers

    Establishment Types

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