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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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Ostial Perfusion Cannula
Spyder Medical
CV.CP01007
In Commercial Distribution

  • B270CVCP010070 ()
  • B270CVCP0100702 ()
  • B270CVCP010071 ()
CV.CP01007

  • Vascular irrigation cannula, coronary artery, single-use
Ostial Perfusion Cannula
Spyder Medical
CV.CP01006
In Commercial Distribution

  • B270CVCP010060 ()
  • B270CVCP010062 ()
  • B270CVCP010061 ()
CV.CP01006

  • Vascular irrigation cannula, coronary artery, single-use
Ostial Perfusion Cannula
Spyder Medical
CV.CP01005
In Commercial Distribution

  • B270CVCP010050 ()
  • B270CVCP010052 ()
  • B270CVCP010051 ()
CV.CP01005

  • Vascular irrigation cannula, coronary artery, single-use
Ostial Perfusion Cannulae
Spyder Medical
CV.CP01004
In Commercial Distribution

  • B270CVCP010040 ()
  • B270CVCP010042 ()
  • B270CVCP010041 ()
CV.CP01004

  • Vascular irrigation cannula, coronary artery, single-use
Thermometer
TOMY INTERNATIONAL, INC.
Y7916
In Commercial Distribution

  • B268Y79161 ()
  • B268Y79160 ()
  • B268Y791695 ()
Y7916

  • General-purpose patient temperature probe, reusable
American Red Cross Infrared non-Contact Forehead Thermometer
TOMY INTERNATIONAL, INC.
Y7790
In Commercial Distribution

  • B268Y77904 ()
  • B268Y77901 ()
  • B268Y77900 ()
Y7790

  • General-purpose patient temperature probe, reusable
Health and Grooming Kit
TOMY INTERNATIONAL, INC.
Y7057A5
In Commercial Distribution

  • B268Y7057A51 ()
  • B268Y7057A53 ()
  • B268Y7057A59 ()
Y7057A5

  • Infant care kit
Ear Thermometer
TOMY INTERNATIONAL, INC.
Y10896
In Commercial Distribution

  • B268Y108964 ()
  • B268Y108961 ()
  • B268Y108960 ()
Y10896

  • General-purpose patient temperature probe, reusable
Single use vaginal speculum with built in light source size small
FTT MEDICAL, INC.
140310
In Commercial Distribution

  • B3961403102 ()
  • B3961403100 ()
  • B3961403101 ()
14-0310

  • Vaginal speculum, single-use
The !SEN-Goggles are used in the assessment of nystagmus by measuring, recording, displaying, and analyzing eye movements. This device consists of patient eye goggles ("ISEN-Goggles"). They have an adjustable, elastic headband, an LCD display, two green LED lights to provide optional focal points, eight infrared LED lights to provide illumination for the internal cameras, an internal SD-type memory, and buttons to operate the device's function. There is also a micro-USS port to facilitate transfer of data captured and stored in the device's SD-type memory. The patient eye goggles are an opaque, facially worn device fitted with two small video cameras, and two wavelengths of light emitting diodes (LEDs). One set of lights provides illumination for the cameras. The other allows the user to provide a focus point for the patient, if this is desired. These signals are processed by the image processor that allows for near-simultaneous viewing of the video images from both eyes on the attached LCD screen.
ISEN Tech. & Trading Co.,Ltd.
V06
In Commercial Distribution

  • B499V062 ()
  • B499V061 ()
  • B499V060 ()


  • Nystagmus inducing optokinetic drum
  • Nystagmus inducing tape
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