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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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TriageHF™ - 00763000351656

SOFTWARE 5242 TRIAGEHF US
MEDTRONIC, INC.
5242
In Commercial Distribution

  • 00763000351656 ()


  • Implantable cardiac device management application software

CareLink SmartSync™ Percepta Serena Solara Application - 00763000002046

SW D00U004 SS PERCEPTA SERENA SOLERA
MEDTRONIC, INC.
D00U004
In Commercial Distribution

  • 00763000002046 ()


  • Implantable cardiac device management application software

CareLink SmartSync™ Azure Astra Application - 00763000002039

SW D00U003 SS AZURE ASTRA
MEDTRONIC, INC.
D00U003
In Commercial Distribution

  • 00763000002039 ()


  • Implantable cardiac device management application software

ShuntCheck III DAQ - 00865435000328

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

BOND - 09349458004859

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

g.Nautilus PRO - EBCI5730PRO0

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

g.Nautilus PRO - EBCI5720PRO0

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

g.Nautilus PRO - EBCI5710PRO0

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

g.Nautilus PRO - EBCI5700PRO0

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
32 FLEXIBLE channels
In Commercial Distribution

  • EBCI5700PRO0 ()
5700PRO

  • Multiple physiological signal amplifier

g.Nautilus PRO - EBCI5220PRO0

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-Channel Sahara
In Commercial Distribution

  • EBCI5220PRO0 ()

  • Channel Number 8
5220PRO

  • Multiple physiological signal amplifier
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