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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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g.Nautilus PRO - EBCI5101PRO0

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-Channel-CSP
In Commercial Distribution

  • EBCI5101PRO0 ()

  • Channel Number 32
5101PRO

  • Multiple physiological signal amplifier

g.Nautilus PRO - EBCI5100PRO0

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-Channel
In Commercial Distribution

  • EBCI5100PRO0 ()

  • Channel Number 32
5100PRO

  • Multiple physiological signal amplifier

SpineUs System - G618000010

The SpineUs™ System is a diagnostic ultrasound system, which consists of the FDA cleared Clarius Ultrasound Scanner C3 HD3 (K213436), a consumer PC, a tracking system with OptiTrack cameras connected to a POE switch and active LED markers, and the SpineUs™ computer application. The SpineUs™ computer application, installed in the consumer PC, processes the ultrasound imaging data received from the Clarius Ultrasound Scanner and the tracking data received from the tracking system. The SpineUs™ computer application allows the operator to view ultrasound images of the spine, segment the ultrasound images using artificial intelligence, generate and visualize 3D reconstructions of the surface of the spine in real-time, measure spine-related anatomical components (e.g., intervertebral angles and spine curvature), review and manage patient measurement data, and generate and export printable reports.
VERDURE IMAGING, INC.
000010
In Commercial Distribution

  • G618000010 ()


  • Ultrasound imaging system operation software
  • Hand-held ultrasound imaging system, body-surface
  • Ultrasound imaging system operator console

Waya Rehab - G741WHREHABV10

Waya® Rehab is a software only medical device to support rehabilitation under the guidance of a qualified healthcare professional.
WELLOVATE, LLC
1
In Commercial Distribution

  • G741WHREHABV10 ()


  • Biomechanical function analysis/interactive rehabilitation system
  • Biomechanical function analysis/rehabilitation software

SHOEBOX Audiometry - B835SHOEBOXAUDIOMETER0

No Description
SHOEBOX Ltd
SHOEBOXAUDIOMETER
In Commercial Distribution



  • Tone audiometer

CamX Proxi Interchangeable Head - E247J27131

No Description
DÜRR DENTAL SE
J2713
In Commercial Distribution

  • E247J27131 ()


  • Intraoral camera

CamX Spectra Interchangeable Head - E247J27121

No Description
DÜRR DENTAL SE
J2712
In Commercial Distribution

  • E247J27121 ()


  • Intraoral camera

CamX Cam Interchangeable Head - E247J27111

No Description
DÜRR DENTAL SE
J2711
In Commercial Distribution

  • E247J27111 ()


  • Intraoral camera

CamX Elara - E247J21101

No Description
DÜRR DENTAL SE
J2110
In Commercial Distribution

  • E247J21101 ()


  • Intraoral camera

ZIRKONZAHN.Implant-Planner Practice - D800SY1620

Rights of use Zirkonzahn.Implant-Planner Practice The conclusion of the Zirkonzahn.Implant-Planner Practice service contract is obligatory for the duration of 12 months! Rights of use for Helpdesk customer support and automatic software updates for Zirkonzahn.Implant-Planner Practice
ZIRKONZAHN SRL
SY1620
In Commercial Distribution

  • D800SY1620 ()


  • Dental treatment application software
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