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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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A handpiece utilized with an all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories (protective eyewear, power cords, tip cleaning kit). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
Fractional Handpiece Kit
In Commercial Distribution

  • 00647529003770 ()
  • 00647529003756 ()
7220002

  • Dental solid-state laser system
A handpiece utilized with an all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories (protective eyewear, power cords, tip cleaning kit). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
Fractional Handpiece Kit
In Commercial Distribution

  • 00647529003633 ()
7220002

  • Dental solid-state laser system
An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories (protective eyewear, power cords, tip cleaning kit, tip holder). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
7200854-03 Refurbished
In Commercial Distribution

  • 00647529002360 ()


  • Dental solid-state laser system
The Fotona SkyPulse Laser Platform consists of a console, a footswitch and attachable laser modules. The Fotona SkyPulse Laser Platform is a multi-application, multi-technology platform that supports the following modules: i) Flash-lamp pumped solid state laser modules and ii) Diode laser modules. Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system microcontroller through an LCD touch-screen.
FOTONA d.o.o.
M321-A
In Commercial Distribution

  • 03830054230392 ()


  • Dental solid-state laser system
  • General/multiple surgical solid-state laser system
  • Multi-modality skin surface treatment system generator
  • Dermatological solid-state laser system
The Fotona SkyPulse Laser Platform consists of a console, a footswitch and attachable laser modules. The Fotona SkyPulse Laser Platform is a multi-application, multi-technology platform that supports the following modules: i) Flash-lamp pumped solid state laser modules and ii) Diode laser modules. Output parameters and other system features are controlled from the touch-screen control panel on the console, which provides an interface to the system microcontroller through an LCD touch-screen.
FOTONA d.o.o.
M321-B
In Commercial Distribution

  • 03830054230408 ()


  • Dental solid-state laser system
  • General/multiple surgical solid-state laser system
  • Multi-modality skin surface treatment system generator
  • Dermatological solid-state laser system
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
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 8000 Hearing Aid Test System performs a broad range of hearing aid measurements from basic, everyday tests of distortion, battery current drain, and frequency response to advanced tests of digital processing delay and phase. The FONIX 8000 is composed of a main electronics module with a front panel for controlling the operation of the analyzer and a wide-format thermal printer. An external video monitor is used to view test results.
FRYE ELECTRONICS, INC.
8000
In Commercial Distribution

  • FONIX8000 ()


  • Hearing aid tester, electrical
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
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