BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    DIROS TECHNOLOGY, INC.

    Reg #: 8043398 · FEI: 3003630373 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    11
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    DIROS TECHNOLOGY, INC.
    Registration Number
    8043398
    FEI Number
    3003630373
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    120 GIBSON DRIVE
    City
    MARKHAM Ontario
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K102566

    Owner / Operator

    Firm Name
    DIROS TECHNOLOGY, INC.
    Operator Number
    9001301
    Address
    120 GIBSON DRIVE
    City
    MARKHAM
    State
    Ontario
    Postal Code
    L3R 2Z3
    Country
    CA
    Correspondent
    Paul Needler

    US Agent

    Business Name
    Avanos Medical, Inc.
    Contact Name
    Amy Winegarden
    Address
    5405 Windward Parkway
    City
    Alpharetta
    State
    GA
    ZIP
    30004
    Country
    US
    Email
    [email protected]
    Phone
    412 9773427

    Products

    Device Name Product Code
    Probe, Radiofrequency Lesion GXI
    Generator, Lesion, Radiofrequency GXD
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Cable, Electrode IKD
    Electrode, Depth GZL

    Proprietary Names

    OWL STERILE SINGLE USE DISPOSABLE CANNULA OWL RF SYSTEM, URF-1A DIROS OWL URF-3AP(ML) OWL URF-3AP OWL GD-PAD PATIENT RETURN ELECTRODE OWL Single Use Disposable RF Probes/Temperature Sensors OWL OWL STERILE SINGLE USE RF INSULATED CANNULAE, MODEL 466 AND DHC URF-2A Owl RF Insulated Cannulae URF-2AP

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device