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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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The portable and fully digital X-ray system Amadeo M-DR mini is for use for first aid services, intensive care units, emergency departments, as well as ships and mobile hospitals (e.g. container solutions) in inaccessible areas, in laboratories and scientific stations in remote parts of the world. The Amadeo M-DR mini is used for wireless digital X-ray imaging. The Amadeo M-AX Version does not contain wireless flat panel detector.
Oehm und Rehbein GmbH
Amadeo M-AX
In Commercial Distribution

  • 04250802900008 ()

  • Weight: 79 Kilogram
AM1000

  • Mobile basic diagnostic x-ray system, digital
The portable and fully digital X-ray system Amadeo M-DR mini is for use for first aid services, intensive care units, emergency departments, as well as ships and mobile hospitals (e.g. container solutions) in inaccessible areas, in laboratories and scientific stations in remote parts of the world. The Amadeo M-DR mini is used for wireless digital X-ray imaging. The Amadeo M-AX Version does not contain wireless flat panel detector.
Oehm und Rehbein GmbH
Amadeo M-AX
Not in Commercial Distribution

  • 04250802902910 ()
  • 04250802902880 ()

  • Weight: 79 Kilogram
AM1000

  • Mobile basic diagnostic x-ray system, digital
RadmediX AcuityUDR combines components into a complete stationary x-ray system, including tube stand, tube head, collimator, generator, a digital radiography panel, and image acquisition software. 21CFR 892.1680 Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
RADMEDIX, LLC
1
In Commercial Distribution

  • 00810035220522 ()


  • Stationary basic diagnostic x-ray system, digital
Scooter, Model: R-100 It is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position. The Scooter (Models: R-100) is an indoor/outdoor electric scooter that is intended to be used by individuals that are able to walk, but suffer from mobility limitations. It has a base with aluminum alloy frame, two front wheels, two rear wheels, two anti-tip wheels, a seat, an adjustable steering column, a control panel, an electric motor, an electromagnetic brake, a rechargeable battery with an off-board charger. The movement of the scooter is controlled by the rider who operates the direction control lever, speed control switch and handle on the control panel. The device is installed with an electromagnetic brake that will engage automatically when the scooter is not in use and the brake cannot be used manually.
Yongkang Dingchang Industry&Trade Co., Ltd.
R100
In Commercial Distribution

  • 06975991680019 ()


  • Assistive scooter, electric-motor-driven
The WS Far-Infrared Therapy Unit, Model: KP-B210, is an infrared heating system which delivers 3~25 μm Far-infrared energy through Far Infrared (FIR) radiation plate. The device is a non-invasive physiology therapy device and emits topical heat to the human forearm and upper arm for therapeutic applications without direct contact. The model, KP-B210 is a single object without additional assembly which contains an emitter, a user control panel, a power switch and safety distance reminder.
WS FAR IR MEDICAL TECHNOLOGY CO., LTD.
KP-B210
In Commercial Distribution

  • 04719873220199 ()


  • Full-body radiant heating system
A 940nm laser system intended for a variety of surgical and oral soft-tissue procedures and dental tooth whitening. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber cable, two surgical handpieces and laser tips, a wireless footswitch and other accessories (power cords, protective eyewear, screen protectors, tip holders). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
Dental soft tissue diode laser system refurbished
In Commercial Distribution

  • 00647529003558 ()
7410004P

  • Dental diode laser system
A 940nm laser system intended for a variety of surgical and oral soft-tissue procedures and dental tooth whitening. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber cable, two surgical handpieces and laser tips, a wireless footswitch and other accessories (power cords, protective eyewear, screen protectors, tip holders). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
7410004
In Commercial Distribution

  • 00647529003541 ()
7410004

  • Dental diode laser system
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU and ELO brand capacitive color touchscreen 24 in. monitor with 1920 x 1080 resolution; International power cord; Z200+ thermal printer(includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, back panel, and keyboard tray; IEC
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260984 ()
XSCRIBE-6AA-DDBAX

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU, no display; UK power cord; Z200+ thermal printer(includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, back panel, and keyboard tray; AHA 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global;
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260908 ()
XSCRIBE-6AB-CDAAA

  • Cardiopulmonary stress exercise monitoring system computer
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module with Trigger Module for TTL/analog signal output; Turnkey system with configured CPU, no display; UK power cord; Z200+ thermal printer(includes starter pack of full-grid paper - A4), XScribe basic transport cart with base, back panel, and keyboard tray; AHA 10 wire, 12-lead lead set with medi-clips; Isolation transformer 1000 VA Med Global;
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094260892 ()
XSCRIBE-6AB-CDAAB

  • Cardiopulmonary stress exercise monitoring system computer
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