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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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The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source), documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon, colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioning within the lumen and help control the endoscope’s view field and/or endoscope positioning.
SMART MEDICAL SYSTEMS LTD
G-EYE760S-V/L
In Commercial Distribution

  • 07290018671030 ()
40-596

  • Flexible fibreoptic colonoscope
The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source), documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon, colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioning within the lumen and help control the endoscope’s view field and/or endoscope positioning
SMART MEDICAL SYSTEMS LTD
G-EYE760P-V/L
In Commercial Distribution

  • 07290018671023 ()
40-596

  • Flexible fibreoptic colonoscope
The G-EYE® colonoscope is intended to be used with a compatible video processor (including light source), documentation equipment, monitor, endotherapy device such as a biopsy forceps, and other ancillary equipment for endoscopy and endoscopic surgery within the lower gastrointestinal tract including the anus, rectum, sigmoid colon, colon and ileocecal valve. It incorporates a balloon at the distal end of the colonoscope to maintain central positioning within the lumen and help control the endoscope’s view field and/or endoscope positioning.
SMART MEDICAL SYSTEMS LTD
G-EYE760R-V/L
In Commercial Distribution

  • 07290018671009 ()
40-596

  • Flexible fibreoptic colonoscope
Behind-the-Ear Hearing Aid
Hetaida Technology Co., Ltd
HTD6101US
In Commercial Distribution

  • 16970289035868 ()
  • 06970289035861 ()


  • Air-conduction hearing aid, receiver-in-the-ear
Non Contact Infrared Body Thermometer
Hetaida Technology Co., Ltd
HTD8813C
In Commercial Distribution

  • 16970289035837 ()
  • 06970289035830 ()


  • Infrared patient thermometer, skin
Non-Contact Infrared Body Thermometer
Hetaida Technology Co., Ltd
HTD8812C
In Commercial Distribution

  • 16970289035776 ()
  • 06970289035779 ()


  • Infrared patient thermometer, skin
Electric Nasal Aspirator
Hetaida Technology Co., Ltd
HTD2602US
In Commercial Distribution

  • 16970289035738 ()
  • 06970289035731 ()


  • Nasal aspirator, electric
Electric Nasal Aspirator
Hetaida Technology Co., Ltd
HTD2601US
In Commercial Distribution

  • 16970289035721 ()
  • 06970289035724 ()


  • Nasal aspirator, electric
Non-Contact Infrared Body Thermometer
Hetaida Technology Co., Ltd
HTD8808C
In Commercial Distribution

  • 16970289035714 ()
  • 06970289035717 ()


  • Infrared patient thermometer, skin
Electric Nasal Aspirator
Hetaida Technology Co., Ltd
H2605US
In Commercial Distribution

  • 16970289035691 ()
  • 06970289035694 ()


  • Nasal aspirator, electric
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