BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EndoDrill Model X with Article No.3000-01 Endodrill Drive System and Article No.1005-40 Endodrill GI 17G

    Reg #: 3027653175 · FEI: 3027653175 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    OMEDTECH
    Registration Number
    3027653175
    FEI Number
    3027653175
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    8501 Lullwater Dr, # 1208
    City
    Dallas
    State
    TX
    ZIP
    75238
    Country
    US

    Regulatory Submissions

    510(k) Number
    K212423

    Owner / Operator

    Firm Name
    OMEDtech
    Operator Number
    10088472
    Address
    PO BOX 1345
    City
    Frisco
    State
    TX
    Postal Code
    75034
    Country
    US
    Correspondent
    David Makanani

    Products

    Device Name Product Code
    Biopsy Needle FCG

    Proprietary Names

    EndoDrill Model X with Article No.3000-01 Endodrill Drive System and Article No.1005-40 Endodrill GI 17G

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198