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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.CP03006
In Commercial Distribution

  • B270CVCP030062 ()
  • B270CVCP030060 ()
  • B270CVCP030061 ()
CV.CP03006

  • Vascular irrigation cannula, coronary artery, single-use
Ostial Perfusion Cannulae
Spyder Medical
CV.CP03004
In Commercial Distribution

  • B270CVCP030042 ()
  • B270CVCP030040 ()
  • B270CVCP030041 ()
CV.CP03004

  • Vascular irrigation cannula, coronary artery, single-use
Ostial Perfusion Cannula
Spyder Medical
CV.CP02007
In Commercial Distribution

  • B270CVCP020072 ()
  • B270CVCP020070 ()
  • B270CVCP020071 ()
CV.CP02007

  • Vascular irrigation cannula, coronary artery, single-use
Ostial Perfusion Cannula
Spyder Medical
CV.CP01007
In Commercial Distribution

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

  • Vascular irrigation cannula, coronary artery, single-use
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
The IB-STIM (DEN180057) is a percutaneous electrical nerve field stimulator (PENFS) system, which is used in a target population of patients 11-18 years of age with functional abdominal pain associated with irritable bowel syndrome (IBS). The IB-STIM is a battery-operated micro-stimulation appliance weighing approximately 5 grams designed as a disposable product for a single use. The IB-STIM is placed behind the patient’s ear and connected to stimulation needles on the auricle. The IB-STIM offers regular therapy over several days and is intended to be used for 120 hours per week up to 3 consecutive weeks. The appliance transmits low-frequency electric pulses to exposed nerve endings.
KEY ELECTRONICS, INC.
IB-STIM
In Commercial Distribution

  • B327NSS2032 ()
  • B327NSS203 ()
  • B327NSS2031 ()
01-1020

  • Opioid withdrawal/irritable bowel symptom-relief periauricular nerve percutaneous electrical stimulator
The NSS Military Field Stimulator (MFS) ((510)K140530) is a percutaneous nerve field stimulator (PNFS) system, which is used in a target population of acute and/or chronic pain. The NSS MFS is a battery-operated micro-stimulation appliance weighing approximately 5 grams designed as a disposable product for a single use. The NSS MFS is placed behind the patient’s ear and connected to stimulation needles on the auricle. The NSS MFS offers regular therapy over several days. The appliance transmits low-frequency electric pulses to exposed nerve endings.
KEY ELECTRONICS, INC.
MFS
In Commercial Distribution

  • B327NSS202 ()
  • B327NSS2022 ()
  • B327NSS2021 ()
01-1011-NSS/MFS

  • Acupuncture electrical stimulation system
The NSS Neurostim ((510)K140530) is a percutaneous nerve field stimulator (PNFS) system, which is used in a target population of acute and/or chronic pain. The NSS Neurostim is a battery-operated micro-stimulation appliance weighing approximately 5 grams designed as a disposable product for a single use. The NSS Neurostim is placed behind the patient’s ear and connected to stimulation needles on the auricle. The NSS Neurostim offers regular therapy over several days. The appliance transmits low-frequency electric pulses to exposed nerve endings.
KEY ELECTRONICS, INC.
Neurostim
In Commercial Distribution

  • B327NSS201 ()
  • B327NSS2012 ()
  • B327NSS2011 ()
01-1021

  • Acupuncture electrical stimulation system
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