BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    ENT/NEURO/OMF System and Accessory (41304KKBA)

    Reg #: 3005820796 · FEI: 3005820796 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    41
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Eberle GmbH & Co. KG
    Registration Number
    3005820796
    FEI Number
    3005820796
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    GLASBRONNENSTRASSE 6
    City
    WURMBERG Baden-Wurttemberg
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K053262

    Owner / Operator

    Firm Name
    EFS-EBERLE FEINWERKTECHN. SYSTEME GMBH & CO. KG
    Operator Number
    9086231
    Address
    GLASBRONNENSTRASSE 6, --
    City
    WURMBERG
    State
    DE-NOTA
    Postal Code
    D-75449
    Country
    DE

    US Agent

    Business Name
    INNOVATIVE ENDOSCOPY COMPONENTS, LLC.
    Contact Name
    GERALDGOIGITZER Goigitzer
    Address
    320 International Pkwy
    City
    Sunrise
    State
    FL
    ZIP
    33325
    Country
    US
    Email
    [email protected]
    Phone
    954 2178780 ext. 0

    Products

    Device Name Product Code
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL

    Proprietary Names

    ENT/NEURO/OMF System and Accessory (41304KKBA) ENT/NEURO/OMF System and Accessory (41201LSA) ENT/NEURO/OMF System and Accessory (41303DT) ENT/NEURO/OMF System and Accessory (41201KN) ENT/NEURO/OMF System and Accessory (41304KKF) ENT/NEURO/OMF System and Accessory (41301GN) ENT/NEURO/OMF System and Accessory (41301SN) ENT/NEURO/OMF System and Accessory (41301LN) ENT/NEURO/OMF System and Accessory (41301LSA) ENT/NEURO/OMF System and Accessory (41301KK) ENT/NEURO/OMF System and Accessory (41303KKB) ENT/NEURO/OMF System and Accessory (41305DW) ENT/NEURO/OMF System and Accessory (41304KKB) ENT/NEURO/OMF System and Accessory (41304W) ENT/NEURO/OMF System and Accessory (41201KKSA) ENT/NEURO/OMF System and Accessory (41303WN) ENT/NEURO/OMF System and Accessory (41301LX) ENT/NEURO/OMF System and Accessory (40711040) ENT/NEURO/OMF System and Accessory (41305DN) ENT/NEURO/OMF System and Accessory (41201KK) ENT/NEURO/OMF System and Accessory (41303KKBA) ENT/NEURO/OMF System and Accessory (41302KN) ENT/NEURO/OMF System and Accessory (41303KNF) ENT/NEURO/OMF System and Accessory (41304KKFA) ENT/NEURO/OMF System and Accessory (41201LN) ENT/NEURO/OMF System and Accessory (41305D) ENT/NEURO/OMF System and Accessory (41301KKSA) ENT/NEURO/OMF System and Accessory (41303KKF) ENT/NEURO/OMF System and Accessory (41301KN) ENT/NEURO/OMF System and Accessory (41303KNB) ENT/NEURO/OMF System and Accessory (41305RN) ENT/NEURO/OMF System and Accessory (41201SN) ENT/NEURO/OMF System and Accessory (41301LXA) ENT/NEURO/OMF System and Accessory (41301KKSB) ENT/NEURO/OMF System and Accessory (41301KSA) ENT/NEURO/OMF System and Accessory (41201KKSB) ENT/NEURO/OMF System and Accessory (41303GNF) ENT/NEURO/OMF System and Accessory (41303KKFA) ENT/NEURO/OMF System and Accessory (41201KSA) ENT/NEURO/OMF System and Accessory (41201GN) ENT/NEURO/OMF System and Accessory (41303GNB)

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)