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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; 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
No Description
ACCUTOME, INC.
24-8000
In Commercial Distribution

  • 00897826002079 ()
24-8000

  • 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
The DGH1912 is a single-element mechanical sector B-scan 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.
DGH1912
In Commercial Distribution

  • 00857377006131 ()


  • Ophthalmic ultrasound imaging transducer
  • Ophthalmic ultrasound imaging system
The DGH1920 is a single-element mechanical sector B-scan 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.
DGH1920
In Commercial Distribution

  • 00857377006124 ()


  • Ophthalmic ultrasound imaging transducer
  • Ophthalmic ultrasound imaging system
The Scanmate Flex is a multi-purpose computer based ultrasonic diagnostic system for ophthalmic application, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL Power. The system consists of three main components: an interface module with integrated probe holder, one or more ultrasonic probes, and the Scanmate software application.
DGH TECHNOLOGY INC.
Scanmate Flex
In Commercial Distribution

  • 00857377006117 ()


  • Ophthalmic ultrasound imaging transducer
  • Ophthalmic ultrasound imaging system
The DGH 8000 is a Portable Ultrasonic B-Scan. It is an electronic device that connects to the user's PC via USB connection. The DGH 8000 uses ultrasonic pulse technology to create 2-dimensional, cross-section images of the human eye.
DGH TECHNOLOGY INC.
DGH 8000
In Commercial Distribution

  • 00857377006100 ()


  • Ophthalmic ultrasound imaging transducer
  • Ophthalmic ultrasound imaging system
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
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