BEUDAMED
    FDA Registration Active 🇺🇸 United States

    NEOTRACT, INC.

    Reg #: 3015181082 · FEI: 3005791775 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    8
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    NEOTRACT, INC.
    Registration Number
    3015181082
    FEI Number
    3005791775
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    4155 HOPYARD ROAD
    City
    Pleasanton
    State
    CA
    ZIP
    94588
    Country
    US

    Regulatory Submissions

    510(k) Number
    K193269

    Owner / Operator

    Firm Name
    NEOTRACT, INC.
    Operator Number
    9088740
    Address
    4155 HOPYARD ROAD
    City
    Pleasanton
    State
    CA
    Postal Code
    94588
    Country
    US
    Correspondent
    Divya Raman

    Products

    Device Name Product Code
    Implantable Transprostatic Tissue Retractor System PEW
    Sterilization Wrap Containers, Trays, Cassettes & Other Accessories KCT

    Proprietary Names

    UroLift System UL400 UroLift System Rigid Retrieval Kit Sterilization Tray UroLift 2 System (UL500) NeoTract UroLift System (UL400) UroLift 2 ATC Advanced Tissue Control System UroLift System Procedure Kit Sterilization Tray UroLift Advanced Tissue Control (ATC) System UroLift 2 System

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility