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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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XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; AM12 Wired Acquisition Module and RScribe with Interpretation; Turnkey system with configured CPU, no display; International power cord; No printer, basic laser transport cart with base and back panel; IEC 10 wire, 12- lead lead set with medi-clips; Isolation transformer 1000 VA Med Global; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259070 ()
XSCRIBE-6HB-DEBAB

  • Cardiopulmonary stress exercise monitoring system computer
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including mounting bracket for Connex Spot Monitor Device (order CSM device separately), PanOptic Ophthalmoscope with Cobalt-Blue Filter and Corneal Viewing Lens (#11820), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, Vital Signs Accessory Basket, Vital Signs Monitor Power Supply (7000-PS), Wall-Mount Panel (34 x 12 in / 86.4 x 30.5 cm); 100-240 V, 50-60 Hz AC, IEC Plug Type-B
WELCH ALLYN, INC.
901027
In Commercial Distribution

  • 00732094230604 ()
77794-2MCSM

  • Aneroid manual sphygmomanometer
The OXYLIGHT IONIX System is a multi-modality skin surface treatment system that uses multiple therapeutic modalities delivered through different attachments or handles connected to a main body. The system includes an LED panel/ lamp that irradiates Blue, Red and Yellow LED light and a Negative ION Mist. The system also includes various handles that deliver a variety of therapeutic modalities including microdermabrasion, LED light and Oxygen spray.
RAJA Medical
OXYLIGHT IONIX
In Commercial Distribution

  • G050OXYLIGHTIONIX0 ()
OXYLIGHT IONIX

  • Multi-modality skin surface treatment system
The IONIXLIGHT System is a multi-modality skin surface treatment system that uses multiple therapeutic modalities delivered through different attachments or handles connected to a main body. The system includes an LED panel/ lamp that irradiates Blue, Red and Yellow LED light and a Negative ION Mist. The system also includes various handles that deliver a variety of therapeutic modalities including microdermabrasion, LED light and Oxygen spray.
RAJA Medical
IONIXLIGHT
In Commercial Distribution

  • G050IONIXLIGHT0 ()
IONIXLIGHT

  • Multi-modality skin surface treatment system
ClearON Mobile provides easy touch based user interface to perform diagnosis of digital radiograph images displayed on ClearOn Mobile. ClearON Mobile receives digital images from a flat panel detector and a X-ray generator. The software also manages patient data, stores and transfers diagnostic images in an internal database.  It supports DICOM image file format which allows interoperability with other Radiography equipment in network environment.  
Rayence Co., Ltd.
ClearON Mobile
In Commercial Distribution

  • 08800018600573 ()


  • Basic diagnostic x-ray system application software
The NIDEK REFRACTOR Model RT-3100 is a computerized refractor used for subjective refraction with the NIDEK AUTO REFRACTOMETER (AR), AUTO REF/KERATOMETER (ARK), AUTO REF/ KER/TONOMETER (RKT), or AUTO LENSMETER (LM) via Eye Care card. The RT-3100 includes a refractor head, control box, and relay box. The relay box not only connects the other two units, but also connects the Chart Presenting device or PC. The control box includes the key panel, display, and printer. The display is a touch-screen panel. The control box displays the data and can be used for almost all operations. In addition, the control box operates the refractor head and the connected chart presenting device. It allows the refractor and charts to be controlled together. Normally, the relay box is installed on the system table (not included in the RT-3100 package.)
NIDEK CO.,LTD.
RT-3100
In Commercial Distribution

  • 04987669100813 ()


  • Phoropter
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
A 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

  • 00647529003473 ()
7410001P

  • Dental diode laser system
A 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.
7410001
In Commercial Distribution

  • 00647529002605 ()
7410001

  • Dental diode 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 holders, tip cleaning kits). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
7200854-05 Refurbished
In Commercial Distribution

  • 00647529002384 ()


  • Dental solid-state laser system
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