BEUDAMED
    FDA Registration Active 🇺🇸 United States

    STERIS Corporation

    Reg #: 3008776287 · FEI: 3008776287 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    34
    Establishment Types
    4
    Classifications
    3

    Registration Details

    Registration Name
    STERIS Corporation
    Registration Number
    3008776287
    FEI Number
    3008776287
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    503 Canal Blvd, ad
    City
    Richmond
    State
    CA
    ZIP
    94804
    Country
    US

    Regulatory Submissions

    510(k) Number
    K223466

    Owner / Operator

    Firm Name
    STERIS Corporation
    Operator Number
    10078069
    Address
    5960 Heisley Road
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US

    Products

    Device Name Product Code
    Ureteroscope And Accessories, Flexible/Rigid FGB
    Camera, Surgical And Accessories KQM
    Light, Surgical, Accessories FTA

    Proprietary Names

    Vision1 Imaging Console and Display System (VIS101) (RM-MF) Uretero 1 Reverse Deflection (URORD101) (RM-SD) Uretero 1 Standard Deflection (UROSD101) (RM-SD) VividImage 32" 4K Surgical display (RM-RR) VividImage 27" 4K Surgical Monitor (RM-CFE) G-Series HD Camera in Case (MG-MF) VividImage 31" 4K Surgical Monitor (RM-CFE) 58" Display Monitor (8MP) (RM-RR) 55" Vividimage W HD Wall Display (RM-RR) HexaVue IP In-Light Camera Control System (RM-MF) M-Series HD Camera (MG-MF) VividImage W 4K 65 4K Medical Wall Display (RM-RR) Vividimage W HD Wall Display (42") (RM-RR) Free 5 Camera System (RM-CFE) Harmony iQ 2800-SLC (RM-CFE) Vividimage D HD Surgical Display (27") (RM-RR) Harmony iQ 2400-SLC (RM-CFE) Harmony iQ 3600-SLC (RM-CFE) IDSS-SLC (version 7 and 8) (RM-CFE) Vividimage T HD Surgical Display (RM-CFE) Vividimage W HD Wall Display 50-inch (RM-CFE) HexaVue Focus In-Light Camera Control System (RM-MF) Vividimage W HD Wall Display 65-inch (RM-RR) A-Series HD Camera (MG-MF) HexaVue Focus Integration System-Surgical Light Control (RM-MF) Hexalux Sterilizable Light Handle (MG-MF) Harmony iQ 3600-SLC (RM-CFE) Sterile Handle Camera Cover (MG-SD, RO-RR) Sterile Light Handle Cover (MG-SD, RO-RR) Universal Light Handle Cover (MG-SD, RO-RR) Harmony iQ 2400-SLC (RM-CFE) Harmony iQ 2800-SLC (RM-CFE) HexaVue IP In-Light Control Systems (RM-MF) IDSS-SLC Version 6 (RM-CFE)

    Establishment Types

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