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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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SUCTION IRRIGATOR
INTUITIVE SURGICAL, INC.
428054
In Commercial Distribution

  • 00886874117293 ()

  • Outer Diameter: 5 Millimeter


  • Robotic surgical irrigation/aspiration cannula, reusable
ENDOSCOPE PORT
INTUITIVE SURGICAL, INC.
428065
In Commercial Distribution

  • 30886874112015 ()
  • 10886874112011 ()
  • 00886874112014 ()

  • Lumen/Inner Diameter: 8.5 Millimeter


  • Laparoscopic multi-instrument access port, single-use
No Description
medimaps group SA
3
In Commercial Distribution

  • B214OSPTM3 ()


  • Bone densitometry ultrasound phantom, test object
  • Bone densitometry x-ray phantom, test object
  • Diagnostic ultrasound phantom, test object
  • CT phantom, test object
  • General-purpose diagnostic x-ray phantom, test object
  • Multi-modality diagnostic imaging phantom, test object
Norav 1200 Series PC-ECG Software Kit for COSMED 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 - I1 = Restin-ECG Measurement The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2-I1
In Commercial Distribution

  • 07290110252793 ()
HASP-SW-K-S2I1-01

  • Cardiovascular risk evaluation interpretive software
  • Cardiopulmonary stress exercise monitoring system computer
Data Acquisition Unit (DAQ) - an electronic connector box which connects a Windows computer running ShuntCheck software to the ShuntCheck Thermosensor
NEURODX DEVELOPMENT LLC
DAQ-1
In Commercial Distribution

  • 00865435000328 ()
DAQ-1

  • Heater/cooler system tester kit
The BacT/ALERT 3D Control Module enables up to 6 incubator modules to be operated from one integrated touchscreen computer.
BIOMERIEUX , INC.
210147
In Commercial Distribution

  • 03573026049522 ()


  • Blood culture analyser IVD
The BOND Controller provides the computer that contains the software (version 6.0/W10 IoT) that controls the processing Module(s).
LEICA BIOSYSTEMS MELBOURNE PTY LTD
BOND Controller (6.0/W10 loT)
In Commercial Distribution

  • 09349458004859 ()
S21.4621

  • Microscope slide stainer IVD
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
19 FLEXIBLE channels
In Commercial Distribution

  • EBCI5730PRO0 ()
5730PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
8 FLEXIBLE channels
In Commercial Distribution

  • EBCI5720PRO0 ()
5720PRO

  • Multiple physiological signal amplifier
The g.Nautilus PRO is intended to be used to acquire the electroencephalogram (EEG) and transmit it wirelessly to a computer.
g.tec medical engineering GmbH
16 FLEXIBLE channels
In Commercial Distribution

  • EBCI5710PRO0 ()
5710PRO

  • Multiple physiological signal amplifier
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