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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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Organ Care System - B00914051

OCS Power Cord, North America
TRANSMEDICS, INC.
1432
In Commercial Distribution

  • B00954033 ()
  • B00914051 ()

  • Height: 2 Inch
  • Width: 10 Inch
  • Length: 8 Inch
1432

  • Electrical mains power cable

Fiagon Navigation Unit - EFIAE0111031

The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The device is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery, such as the paranasal sinuses, mastoid anatomy, can be identified relative to a CT or MR based model of the anatomy This also comprises of accessories 1) Extension cable instrument 2) Extension Cable localizer 3) FootSwitch 4) Double Instrument support 5) PC mouse 6) Service Keyboard 7)DVI monitor cable 8) VGA monitor cable 9)Monitor cable control 10) HDMI monitor cable 11) Composite video Cable 12) Power Cable (US)
Fiagon GmbH
1
Not in Commercial Distribution

  • EFIAE0111031 ()
  • EFIAE0111030 ()

  • Height: 135 Millimeter
  • Width: 315 Millimeter
  • Weight: 11.7 Kilogram
  • Length: 365 Millimeter


  • Multi-purpose stereotactic surgery system

XDR CLARITY - D787XDR4P10ACSZ10

XDR CLARITY - Size-1 Digital Intraoral Sensor
CYBER MEDICAL IMAGING, INC.
XDR4P10SZ1
In Commercial Distribution

  • D787XDR4P10ACSZ10 ()

  • Length: 36.2 Millimeter
  • Width: 24.2 Millimeter
  • Height: 5.5 Millimeter


  • Dental digital imaging sensor, intraoral

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

Procam HD CMOS II CONSOLE - B366U1HC120G21

Procam HD CMOS II CONSOLE
Ecleris
R03
In Commercial Distribution

  • B366U1HC120G21 ()
U1HC120G21

  • Surgical video camera

MICROSCOPE - B366U1OM100F1LR01

MICROSCOPE
Ecleris
R01
In Commercial Distribution

  • B366U1OM100F1LR01 ()
U1OM100F1L

  • General-purpose surgical microscope

Freespira - B185SM40500

Biofeedback device that provides respiration rate and exhaled CO2 levels as part of treatment for Panic Disorder, Panic Attacks, and Post Traumatic Stress Disorder.
Freespira, Inc.
3
In Commercial Distribution

  • B185SM40500 ()
04275

  • Psychophysiological biofeedback system
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