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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; 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; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259438 ()
XSCRIBE-6DB-DEBAX

  • 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 and RScribe with Interpretation; Software kit; International power cord; No printer, basic laser transport cart with base and back panel; IEC 10 wire, 12-lead lead set with medi-clips; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259278 ()
XSCRIBE-6EC-DEBXX

  • 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; Software kit; 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 + CareFusion CP Interface
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094294569 ()
XSCRIBE-6CC-DEBAE

  • Cardiopulmonary stress exercise monitoring system computer
Welch Allyn Green Series 777 Integrated Wall Diagnostic System including Connex ProBP 3400 Digital Blood Pressure Device with SureBP (#34XFWT-B), SureTemp Plus 690 Electronic Thermometer (#01690-300), PanOptic Ophthalmoscope with Cobalt-Blue Filter and Corneal Viewing Lens (#11820), MacroView Otoscope (#23810), KleenSpec Disposable Specula Dispenser, 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

  • 00732094066838 ()
77791-2MPXPROBP

  • Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
The OXYLIGHT 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 Oxygen Spray. The system also includes various handles that deliver a variety of therapeutic modalities for skin rejuvenation.
RAJA Medical
OXYLIGHT
In Commercial Distribution

  • G050OXYLIGHT0 ()


  • Multi-modality skin surface treatment system
Application for sending a live video stream from the medical operating theater to remote viewers. The class of HW devices with or without a touch panel display (TPD). It is used to connect to a video source and capture, archive and stream the video to the Orpheus System central server and over the multi-cast network to be viewed from the Orpheus Show application.
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025032 ()
MCU-EG00407

  • Electrosurgical system monitor/shield
Application for sending a live video stream from the medical operating theater to remote viewers. The class of HW devices with or without a touch panel display (TPD). It is used to connect to a video source and capture, archive and stream the video to the Orpheus System central server and over the multi-cast network to be viewed from the Orpheus Show application.
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025025 ()

  • Depth: 21 Centimeter
  • Height: 60 Centimeter
  • Width: 74 Centimeter
  • Weight: 13.2 Kilogram
MCU-EG00402

  • Electrosurgical system monitor/shield
Application for sending a live video stream from the medical operating theater to remote viewers. The class of HW devices with or without a touch panel display (TPD). It is used to connect to a video source and capture, archive and stream the video to the Orpheus System central server and over the multi-cast network to be viewed from the Orpheus Show application.
ORPHEUS MEDICAL LTD
01
In Commercial Distribution

  • 07290017025018 ()

  • Depth: 20 Centimeter
  • Height: 56 Centimeter
  • Width: 63 Centimeter
  • Weight: 10.6 Kilogram
MCU-EG00401

  • Electrosurgical system monitor/shield
The NuEye™ Tracking System is setting a new standard for eye gaze systems. Compatible with the Accent 1400, Accent 1200* and Accent 1000, now you can access the full communication & computing power with just your eyes! Note: Photos show NuEye™ Tracking System module only and attached to an Accent 1400. The NuEye Tracking System attaches quickly to the Accent 1400, Accent 1200 or Accent 1000 device to give users full visual control of the device. Keys are "selected" by gazing for a specified period of time to generate speech. Developed in partnership with SensoMotoric Instruments GmbH (SMI) of Germany, a global leader in eye tracking technology for more than 20 years. NuEye is ideal for children and adults who need hands-free and switch-free device access.
PRENTKE ROMICH COMPANY
NE
In Commercial Distribution

  • 00858526006590 ()

  • Weight: 0.29 Pound


  • Voice synthesizer/digitizer
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.
All tissue YSGG dental laser system,pearl white, premier
In Commercial Distribution

  • 00647529542019 ()
7200854-201

  • 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). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
All tissue YSGG dental laser system, platinum SG2
In Commercial Distribution

  • 00647529004777 ()
7200854-09W

  • 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). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
All tissue YSGG dental laser system, red SG2
In Commercial Distribution

  • 00647529004722 ()
7200854-02W

  • 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). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
All tissue YSGG dental laser system, rose gold premier
In Commercial Distribution

  • 00647529004456 ()
7200854-217

  • 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). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
All tissue YSGG dental laser system, jungle premier
In Commercial Distribution

  • 00647529004449 ()
7200854-214

  • 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). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
All tissue YSGG dental laser system, aquarium premier
In Commercial Distribution

  • 00647529004432 ()
7200854-213

  • 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). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
All tissue YSGG dental laser system, yellow premier
In Commercial Distribution

  • 00647529004425 ()
7200854-212

  • 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). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
All tissue YSGG dental laser system, purple w/ C&V indication
In Commercial Distribution

  • 00647529004418 ()
7200854-211

  • 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). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
All tissue YSGG dental laser system, burnt orange premier
In Commercial Distribution

  • 00647529004395 ()
7200854-207

  • 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). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
All tissue YSGG dental laser system , bright lime premier
In Commercial Distribution

  • 00647529004388 ()
7200854-205

  • 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). The patient-contacting components of the delivery system require sterilization prior to use.
Biolase, Inc.
All tissue YSGG dental laser system , midnight blue premier
In Commercial Distribution

  • 00647529004371 ()
7200854-204

  • Dental solid-state laser system
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