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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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HScribe Review Workstation - version 6 for HScribe review, edit, and signing capabilities. Includes current software CD and user manual CD; Turnkey workstation with configured CPU and color LCD 24" monitor with 1920 x 1080 resolution; Australia power cord; No printer
WELCH ALLYN, INC.
901143
Not in Commercial Distribution

  • 00732094301564 ()
HSCRIBWS-6AA-BXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software
HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software activation only; No power cord, activation only; No printer; No connectivity
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094286137 ()
HSCRIBE-6AD-ZXXXX

  • Electrocardiographic long-term ambulatory recording analyser application software
HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; Australia power cord; No printer; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264098 ()
HSCRIBE-6AC-BXXXB

  • Electrocardiographic long-term ambulatory recording analyser application software
XScribe Cardiac Stress - version 6 with adult and pediatric interpretation; includes current software CD and User Manual CD; WAM Wireless Acquisition Module; Software kit; No power cord; No printer, no transport cart; No lead set; No isolation transformer; No connectivity
WELCH ALLYN, INC.
901144
In Commercial Distribution

  • 00732094259476 ()
XSCRIBE-6CC-XXXXX

  • Cardiopulmonary stress exercise monitoring system computer
HScribe Holter Analysis System - version 6 with adult and pediatric arrhythmia analysis. Includes current software CD, user manual CD, CF card reader, and H3+ USB interface cable; Standard model; Software kit; UK power cord; No printer; Report Export + DICOM bidirectional Interface
WELCH ALLYN, INC.
901143
In Commercial Distribution

  • 00732094264074 ()
HSCRIBE-6AC-CXXXB

  • Electrocardiographic long-term ambulatory recording analyser application software
The NIDEK US-500 Echoscan is an ultrasonic device to measure the axial length and corneal thickness and provide the information to be used for diagnosis. Axial length is one of the parameters used to determine the refractive power of an IOL prior to cataract surgery. By inputting the measured axial length with other parameters, the refractive power of an IOL can be calculated. Corneal thickness is a necessary parameter when considering the clinical influence of surgery, drugs and contact lenses upon endothelium tissue. Pachymetry is now commonly performed prior to and after corneal refractive surgery using devices such as the excimer laser. The US-500 is comprised of a touch screen, main body with a built-in printer, Pachymetry probe, and foot switch.
NIDEK CO.,LTD.
US-500
In Commercial Distribution

  • 04987669100455 ()


  • Ophthalmic ultrasound imaging system
  • Ultrasound pachymeter
Ultrasonic waves are the sound waves pitched above the range of human hearing whose frequency is 20,000 Hz or more. In the medical field, ultrasonic waves of frequencies between 1 and 15 MHz are applied, and these types of high sound waves have the following characteristics similar to light: They have a high tendency to travel in a straight direction. They have characteristics such as reflect.
NIDEK CO.,LTD.
US-4000
In Commercial Distribution

  • 04987669100448 ()


  • Ultrasound pachymeter
  • Ophthalmic ultrasound imaging system
The DGH1500-50 is a 50 MHz ultrasonic element that is for use with the DGH1500 UBM Probe.
DGH TECHNOLOGY INC.
DGH1500-50
In Commercial Distribution

  • 00857377006162 ()


  • Ophthalmic ultrasound imaging transducer
  • Ophthalmic ultrasound imaging system
The DGH1500-35 is a 35 MHz ultrasonic element that is for use with the DGH1500 UBM Probe.
DGH TECHNOLOGY INC.
DGH1500-35
In Commercial Distribution

  • 00857377006155 ()


  • Ophthalmic ultrasound imaging transducer
  • Ophthalmic ultrasound imaging system
The DGH1500 is a single-element mechanical sector UBM probe. This probe connects to the Scanmate Flex USB interface module, which is, in turn, connected via a USB cable to a PC running the DGH Scanmate software.
DGH TECHNOLOGY INC.
DGH1500
In Commercial Distribution

  • 00857377006148 ()


  • Ophthalmic ultrasound imaging transducer
  • Ophthalmic ultrasound imaging system
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