BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TRICE MEDICAL

    Reg #: 3010760216 · FEI: 3010760216 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    16
    Establishment Types
    4
    Classifications
    10

    Registration Details

    Registration Name
    TRICE MEDICAL
    Registration Number
    3010760216
    FEI Number
    3010760216
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    40 General Warren Blvd, Suite 100
    City
    Malvern
    State
    PA
    ZIP
    19355
    Country
    US

    Regulatory Submissions

    510(k) Number
    K141119

    Owner / Operator

    Firm Name
    Trice Medical
    Operator Number
    10046410
    Address
    40 General Warren Blvd, Suite 100
    City
    Malvern
    State
    PA
    Postal Code
    19355
    Country
    US
    Correspondent
    David Vancelette

    Products

    Device Name Product Code
    Tray, Surgical, Instrument FSM
    Probe HXB
    Arthroscope HRX
    Kit, Surgical Instrument, Disposable KDD
    Guide, Surgical, Instrument FZX
    Orthopedic Manual Surgical Instrument LXH
    Instrument, Ultrasonic Surgical LFL
    System, Imaging, Pulsed Doppler, Ultrasonic IYN
    Transducer, Ultrasonic, Diagnostic ITX
    System, Imaging, Pulsed Echo, Ultrasonic IYO

    Proprietary Names

    SegWAY Instrument Case mi-probe mi-eye SegWay Disposable ECTR Kit Advansor Trigger Finger Release System SegWAY Guides C-MOR Visualization Device mi-eye 3 mi-eye 2 mi-tablet 2 SegWAY Instruments Tenex 2nd Generation System Tenex 2nd Generation Console Tenex 2nd Generation MicroTip mi-ultra LR mi-ultra CX

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility Repack or Relabel Medical Device