BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SHEATHING TECHNOLOGIES, INC.

    Reg #: 2950776 · FEI: 1000135740 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    7
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    SHEATHING TECHNOLOGIES, INC.
    Registration Number
    2950776
    FEI Number
    1000135740
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    675 JARVIS DR.
    City
    MORGAN HILL
    State
    CA
    ZIP
    95037
    Country
    US

    Regulatory Submissions

    510(k) Number
    K043425

    Owner / Operator

    Firm Name
    SHEATHING TECHNOLOGIES, INC.
    Operator Number
    9006763
    Address
    675 JARVIS DR, --
    City
    Morgan Hill
    State
    CA
    Postal Code
    95037
    Country
    US
    Correspondent
    LAWRENCE S POLAYES

    Products

    Device Name Product Code
    Transducer, Ultrasonic, Diagnostic ITX
    Biopsy Needle Guide Kit OIJ
    Radiology-Diagnostic Kit OIP
    Media, Coupling, Ultrasound MUI
    Endoscopic Contamination Prevention Sheath ODB
    Colonoscope And Accessories, Flexible/Rigid FDF

    Proprietary Names

    Sheathes Needle Guide System Sheathes Ultrasound Probe Covers Sheathes Sheathes3D Sheathes Sterile Ultrasound Gel SheathesISO Sheathes Ultrasound Gel

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device