BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Chromophare Surgical Light System

    Reg #: 2031963 · FEI: 3002975342 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    52
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    STRYKER Communications, Inc.
    Registration Number
    2031963
    FEI Number
    3002975342
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    571 Silveron Blvd.
    City
    Flower Mound
    State
    TX
    ZIP
    75028
    Country
    US

    Owner / Operator

    Firm Name
    STRYKER CORP.
    Operator Number
    1811755
    Address
    4100 East Milham Ave.
    City
    Kalamazoo
    State
    MI
    Postal Code
    49001
    Country
    US

    Products

    Device Name Product Code
    Light, Surgical, Ceiling Mounted FSY

    Proprietary Names

    Chromophare Surgical Light System ACCEND Flat Panel Covers/Caps ACCEND Lighthead Electronics Repair ACCEND Ceiling Cover Hardware ACCEND Suspension, FP/L/L, 1400/1300/1200mm ACCEND Suspension, L/FP, 1050/925mm ACCEND Rotating Soffit Assembly ACCEND Power Supply ACCEND L/L Classic, 1050/925mm ACCEND Light Flat, 1050mm ACCEND FP/L/L Classic, 1200/1050/925mm ACCEND Handle Cover, Sterilizable ACCEND Drop Tube, 400 mm, M12 ACCEND Drop Tube, 150 mm, M12 ACCEND Light Classic, 1050mm ACCEND Lighthead with Flat Cardanic ACCEND Cardanic Control Repair ACCEND Flat Panel Hardware ACCEND L/FP Flat, 1050/925mm ACCEND Handle Adapter, Devon SlipOn ACCEND LIGHT HEAD PACKAGING KIT ACCEND Spring Arm, Flat, no stop 12-21kg ACCEND LONG SUSPENSION PACKAGING KIT ACCEND Drop Tube, 350mm ACCEND Drop Tube, 400mm ACCEND L/FP Flat, 1300/1200mm ACCEND SPRING ARM PACKAGING KIT ACCEND Suspension Hardware ACCEND L/L Flat, 1300/1200mm ACCEND Suspension Covers/Caps ACCEND DROP TUBE HARDWARE KIT ACCEND Spring Arm, Classic, no stop 12-21kg ACCEND Conduit Termination Plate ACCEND SUSPENSION PACKAGING KIT ACCEND Spring Arm, Classic, stop 12-21kg ACCEND Handle Adapter, Devon ScrewOn ACCEND Drop Tube, 250 mm, M12 ACCEND Suspension, Light, 1050mm ACCEND Spring Arm Covers/Caps ACCEND Lighthead with Classic Cardanic ACCEND Suspension, L/L, 1050/925mm ACCEND Spring Arm Hardware ACCEND Drop Tube, 150mm ACCEND Suspension, L/FP, 1300/1200mm ACCEND Suspension, FP/L/L, 1200/1050/925mm ACCEND Cardanic Caps ACCEND Flat Panel Mount ACCEND Suspension, L/L, 1300/1200mm ACCEND FP/L/L Flat, 1400/1300/1200mm ACCEND L/FP Classic, 1050/925mm ACCEND Handle Adapter, Sterilizable ACCEND Ceiling Cover

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device