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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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FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC
5600050
In Commercial Distribution

  • D82856000500 ()


  • Orthodontic palate expander/teeth aligner, bonded
Surveyor Repeater Node with no Hardware Italian language and CD manual; 220V power; No display monitor
WELCH ALLYN, INC.
901140
Not in Commercial Distribution

  • 00732094325362 ()
SCREP-DEB-XXXXX

  • Centralized patient monitor
Procellera Power Pack, 4" Diameter, & Energel
Vomaris Wound Care, Inc.
4"Diam CD & Energel
In Commercial Distribution

  • 00810198030259 ()
VHK-D04-05

  • Bioelectric wound dressing
Procellera Power Pack, 4"x4" Composite, & Energel
Vomaris Wound Care, Inc.
4"x4" CD & Energel
In Commercial Distribution

  • 00810198030266 ()
VHK-0404-05

  • Bioelectric wound dressing
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
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
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