BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GIS Endoscopic Optical Lens

    Reg #: 3011178147 · FEI: 3011178147 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    GI SCIENTIFIC LLC
    Registration Number
    3011178147
    FEI Number
    3011178147
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1765 Greensboro Station Pl Ste 900
    City
    Mc Lean
    State
    VA
    ZIP
    22102
    Country
    US

    Regulatory Submissions

    510(k) Number
    K140295

    Owner / Operator

    Firm Name
    GI Scientific LLC
    Operator Number
    10047640
    Address
    1765 Greensboro Station Place, Suite 900
    City
    McLean
    State
    VA
    Postal Code
    22102
    Country
    US
    Correspondent
    Scott R Miller

    Products

    Device Name Product Code
    Instrument, Special Lens, For Endoscope FEI
    Gastroscope And Accessories, Flexible/Rigid FDS

    Proprietary Names

    GIS Endoscopic Optical Lens

    Establishment Types

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