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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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The Saneso Box incorporates state of the art electronics and software and is the brain behind Saneso’s endoscopy system. It executes all technological innovations incorporated in the Saneso colonoscope and gastroscope.
Saneso Inc.
G347SBA
In Commercial Distribution

  • G347SBA0 ()


  • Endoscopic control/video-imaging system
GoCheck i7P MultiScreener Finished Device Assembly
Gobiquity, Inc.
i7 Plus
In Commercial Distribution

  • B43071000020 ()


  • External ocular measurement camera
  • Tone audiometer
  • Vision testing/training chart
No Description
CLEAR GUIDE MEDICAL, INC.
CGTT
In Commercial Distribution

  • B201CGTT1 ()
  • B201CGTT0 ()
  • B201CGTT2 ()


  • Imaging lesion localization marker, external, single-use
  • Surgical optical-tracking spatial marker, single-use
QUASAR MRgRT Insight (MRDQA) Phantom - Support Base Package. Includes Support base and upright sections with 1 laser alignment target, User’s Guide, Heavy Duty Case, and software for 1 MR scanner with unlimited scans.
Modus Medical Devices Inc
100-1023-100
In Commercial Distribution

  • G34310010231000 ()


  • Multi-modality therapeutic radiation phantom, test object
FedMedMicFiUVWP, with white light, UV light and polarizing filter, is a digital dermatoscope with Wi-Fi transmission. With special software and Apps included you can capture photos and videos both from PC and from Smartphone and Tablet.
BELLEGROVE MEDICAL SUPPLY, INC.
BTS-106
Not in Commercial Distribution

  • B1621061 ()


  • Otoscope, direct
Application- impedance analysis software utilizing impedance ratios that are displayed as an L-Dex ratio that supports the measurement of extracellular fluid volume differences between the limbs and is presented to the clinician on an L-Dex scale.
IMPEDIMED LIMITED
1.1.0
Not in Commercial Distribution

  • B277SOZOTHRIVE0 ()
SOZOthrive

  • Bioelectrical body composition analyser
The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE17 model is a panel PC with a 17" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE17
In Commercial Distribution

  • B201CGCORE170 ()
  • B201CGCORE171 ()
CG-CORE17

  • Ultrasound imaging system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Panel computer
Varia-NCI accesses data from Varia TCD, a digital Transcranial Doppler (TCD) Ultrasound device. Varia-NCI is an intuitive software program that provides clinicians information on a patient’s cerebrovascular regulation by reporting key physiologic parameters, including the Neurovascular Complexity Index (NCI). Through high performance analytical processing of a TCD recording, it delivers quantitative Cerebral Blood Flow Velocity (CBFV) variability results to clinicians managing head trauma. Varia-NCI is an accessory application to the Varia TCD device. Software only device and accessory to Varia TCD.
NEUROCHAOS SOLUTIONS INC
1
In Commercial Distribution

  • B412779815 ()
7798

  • Noninvasive vascular ultrasound system, line-powered
T-Scan Core Software, 1 Novus Handpiece (USB Connection), 1 Novus Handpiece Holder, 20 Large & 20 Small Sensors, 2 Large & 2 Small Sensor Supports, 90 Day Free Customer Support, One Year Parts & Labor Warranty, Interactive Help File, Electronic Operations Manual.
Tekscan, Inc.
T-Scan Novus Core System
In Commercial Distribution

  • B970DC10 ()
DC1

  • Dental articulation paper
The CamX Spectra Fluorescence Caries Detection Aid System aids in the diagnosis of caries. It consists of a toothbrush-sized handpiece for examining the condition of a tooth, an umbilical cord connecting the handpiece to a computer and imaging software.
AIR TECHNIQUES, INC.
G4100
In Commercial Distribution

  • D678G41000 ()
  • D678G40001 ()
  • DG78G41001 ()


  • Dental caries detector, optical induced fluorescence
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