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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 Class Implantable

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Disposable Reflective Spheres attached to reference frames and surgical instruments for use during surgical navigation in image guided surgery. One retail carton is made up of 1 sphere per tray in a pouch. There are 12 tray-in-pouches for a total of 12 spheres.
Northern Digital Inc
8801051
In Commercial Distribution

  • 00805832020017 ()
  • 20805832020011 ()
8801051

  • Imaging lesion localization marker, external, single-use
REAL INTELLIGENCE FLAT MARKERS
Smith & Nephew, Inc.
ROB10032
In Commercial Distribution

  • 30885556757476 ()
  • 20885556757479 ()
  • 00885556757475 ()
ROB10032

  • Imaging lesion localization marker, external, single-use
AUDIOMETER. Piccolo Basic Aero is a portable audiometer that can be controlled from a Windows computer or iPad. Available exams: pure tone audiometry via air conduction.
INVENTIS SRL
PICCOLO BASIC AERO
In Commercial Distribution

  • 08054187380358 ()
10328

  • Tone audiometer, manual
Trumpet REM & AUD is - a Real Ear Measurement (REM) system capable of assessing all the in-situ parameters required for a complete hearing aid fitting process, and - a diagnostic audiometer capable of performing pure tone and speech audiometry, in air, free field, and in bone conduction.
INVENTIS SRL
TRUMPET REM & AUD
In Commercial Distribution

  • 08054187380570 ()
10969

  • Tone audiometer
  • Ear canal insertion gain measurement instrument
EndoFLIP Measurement Catheter for use with EndoFLIP System
CROSPON LIMITED
EF-322
In Commercial Distribution

  • 05391530810029 ()


  • Oesophageal motility analysis system
  • Manometric gastrointestinal motility analysis system
  • Gastrointestinal barostat
No Description
Inmedico A/S
USB350-SP
Not in Commercial Distribution

  • 05713557000120 ()


  • Speech audiometer
  • Tone audiometer, manual
  • Tone audiometer, automated
  • Tone audiometer
No Description
Inmedico A/S
SM450-FF
Not in Commercial Distribution

  • 05713557000083 ()


  • Speech audiometer
  • Tone audiometer, automated
  • Tone audiometer, manual
  • Tone audiometer
No Description
Inmedico A/S
SM960-C
Not in Commercial Distribution

  • 05713557000076 ()


  • Tone audiometer
  • Speech audiometer
  • Tone audiometer, automated
  • Tone audiometer, manual
No Description
Inmedico A/S
SM950-S
Not in Commercial Distribution

  • 05713557000069 ()


  • Tone audiometer
  • Speech audiometer
  • Tone audiometer, manual
  • Tone audiometer, automated
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer) - S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools - I3 = Resting-ECG Measurement and Interpretation MEANS (Uni. of Rotterdam, NL) - D1 = Norav ECG Management System NEMS The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2-I3-D1
In Commercial Distribution

  • 07290110252816 ()
HASP-SW-K-S2I3D1-01

  • Cardiovascular risk evaluation interpretive software
  • Cardiopulmonary stress exercise monitoring system computer
  • Patient-administration information system application software
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