BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    GERDX - Tissue Retractor

    Reg #: 3033508651 · FEI: 3033508651 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    5
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    G-SURG GMBH
    Registration Number
    3033508651
    FEI Number
    3033508651
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Weinbergstrasse 28
    City
    Seeon-Seebruck Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K233240

    Owner / Operator

    Firm Name
    G-SURG GmbH
    Operator Number
    10091470
    Address
    Weinbergstrasse 28
    City
    Seeon-Seebruck
    State
    Bavaria
    Postal Code
    83370
    Country
    DE
    Correspondent
    Julian Mair

    US Agent

    Business Name
    G-SURG USA, Inc.
    Contact Name
    Julian Mair
    Address
    80 Pine St Fl 24
    City
    New York
    State
    NY
    ZIP
    10005
    Country
    US
    Email
    [email protected]
    Phone
    212 5849708

    Products

    Device Name Product Code
    Endoscopic Suture/Plication System, Gastroesophageal Reflux Disease (Gerd) ODE

    Proprietary Names

    GERDX - Tissue Retractor GERDX - Guide Wire GERDX - Suture System GERDX - Applicator GERDX - Implant System

    Establishment Types

    Manufacture Medical Device