BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PHANTOM XL INSULATED DILATORS

    Reg #: 3005726885 · FEI: 3005726885 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    TEDAN SURGICAL INNOVATIONS, INC.
    Registration Number
    3005726885
    FEI Number
    3005726885
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    12320 Cardinal Meadow Drive, Suite #150
    City
    Sugar Land
    State
    TX
    ZIP
    77478
    Country
    US

    Regulatory Submissions

    510(k) Number
    K140088

    Owner / Operator

    Firm Name
    TEDAN SURGICAL INNOVATIONS, INC.
    Operator Number
    9086980
    Address
    12320 Cardinal Meadow Drive, Suite #150
    City
    Sugar Land
    State
    TX
    Postal Code
    77478
    Country
    US

    Products

    Device Name Product Code
    Neurosurgical Nerve Locator PDQ

    Proprietary Names

    PHANTOM XL INSULATED DILATORS

    Establishment Types

    Repack or Relabel Medical Device Develop Specifications But Do Not Manufacture At This Facility