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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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Thoraguard Chest Tube Kit, 28 Fr
CENTESE, INC.
FGS-2000
In Commercial Distribution

  • 00860000436441 ()

  • Catheter Gauge: 28 French
TGCT120028

  • Mediastinal drainage catheter, non-antimicrobial
  • Pleural catheter
  • Sump drain
Thoraguard Chest Tube Kit, 20 Fr
CENTESE, INC.
FGS-1126
In Commercial Distribution

  • 10860000436400 ()
  • 00860000436403 ()

  • Catheter Gauge: 20 French
TGCT120020

  • Mediastinal drainage catheter, non-antimicrobial
  • Pleural catheter
  • Sump drain
Reusable Vaginal Speculum
CEEK WOMEN'S HEALTH
NU001
In Commercial Distribution

  • 10860000270424 ()
  • 00860000270427 ()


  • Vaginal speculum, reusable
Single-Use Retraction Sheath
CEEK WOMEN'S HEALTH
VS000
In Commercial Distribution

  • 00860000270403 ()
  • 10860000270400 ()


  • Vaginal speculum, single-use
VirtuOst uses data from computed tomography scans to estimate bone mineral density, bone strength, and a load-to-strength ratio. This information can be used by a physician to assess fracture risk, identify osteoporosis, and monitor therapy. For pediatric patients, VirtuOst provides these estimates without any classifications and should be used only when the benefit of obtaining these estimates outweighs the risk of radiation.
O N DIAGNOSTICS LLC
A
In Commercial Distribution

  • 00860000233101 ()


  • Radiology DICOM image processing application software
The Light Jacket® Attachable Light for Electrosurgical Pencil is offered as a sterile, one-time use disposable medical device for providing enhanced illumination of the surgical site when attached to an electrosurgical pencil.
PATHY MEDICAL, LLC
PM-LJ100
In Commercial Distribution

  • 00860000230704 ()
  • 00860000230711 ()


  • Operating room light
No Description
Rst- Sanexas
RST-SANEXAS PT
In Commercial Distribution

  • 00860000214049 ()


  • Transcranial electrical stimulation system, pulsed-current
No Description
Rst- Sanexas
RST-SANEXAS Basic
In Commercial Distribution

  • 00860000214032 ()


  • Transcranial electrical stimulation system, pulsed-current
RSI-MRI+ is standalone software that is used by radiologists, urologists, and other clinicians to assist with analysis and interpretation of medical images. RSI-MRI+ accepts DICOM images using supported protocols and performs automatic post-acquisition analysis of diffusion-weighted magnetic resonance imaging (DWI) data and optional automated fusion of derived image data with anatomical T2-weighted MR images. Some of the features of RSI-MRI+ include: • Restricted Signal Map: The derived image data produced by RSI-MRI+ includes an enhanced DWI map (the Restricted Signal Map), which demonstrates improved conspicuity of restricted diffusion compared to standard DWI maps. • Color Fusion Series: RSI-MRI+ can be configured to produce a color fusion series which overlays the Restricted Signal Map intensity onto the anatomical T2-weighted image series. • Automated Prostate Segmentation: RSI-MRI+ uses artificial intelligence (AI) powered by a deep learning algorithm to automatically segment the prostate on anatomical T2-weighted images. The segmentation result is provided in the separate Prostate Segmentation Series. • Automated Segmentation Report: RSI-MRI+ generates a report of segmentation volume and images of the segmented prostate as a colored outline on the anatomical image. • Export: RSI-MRI+ outputs are provided in standard DICOM format, which is compatible with most third-party commercial PACS workstation software. NOTE: The RSI-MRI+ supported protocols differ from PI-RADS v2.1 in that they have lower inplane resolution for T2W images and thicker slices for the GE DW
CORTECHS LABS INC
1.1
In Commercial Distribution

  • 00860000004817 ()


  • Radiology DICOM image processing application software
PERFORATED TRAY WITH FEET 242x252x80MM
BAHADIR USA LLC
Y380.07F
In Commercial Distribution

  • 00859982006964 ()


  • Instrument tray, reusable
PERFORATED TRAY WITH FEET 242x252x60MM
BAHADIR USA LLC
Y380.05F
In Commercial Distribution

  • 00859982006957 ()


  • Instrument tray, reusable
PERFORATED TRAY WITH FEET 242x252x40MM
BAHADIR USA LLC
Y380.03F
In Commercial Distribution

  • 00859982006940 ()


  • Instrument tray, reusable
PERFORATED TRAY WITH FEET 405X252X80MM
BAHADIR USA LLC
Y280.07F
In Commercial Distribution

  • 00859982006933 ()


  • Instrument tray, reusable
PERFORATED TRAY WITH FEET 405X252X60MM
BAHADIR USA LLC
Y280.05F
In Commercial Distribution

  • 00859982006926 ()


  • Instrument tray, reusable
PERFORATED TRAY WITH FEET 539X252X80MM
BAHADIR USA LLC
Y181.07F
In Commercial Distribution

  • 00859982006919 ()


  • Instrument tray, reusable
PERFORATED TRAY WITH FEET 539X252X60MM
BAHADIR USA LLC
Y181.05F
In Commercial Distribution

  • 00859982006902 ()


  • Instrument tray, reusable
PERFORATED TRAY WITH FEET 484X252X40MM
BAHADIR USA LLC
Y180.03F
In Commercial Distribution

  • 00859982006896 ()


  • Instrument tray, reusable
SILICONE MAT PERFORATED LG 500x235mm
BAHADIR USA LLC
Y852.31
In Commercial Distribution

  • 00859982006377 ()
940400

  • Instrument tray, reusable
SILICONE MAT PERFORATED MED 370x235mm
BAHADIR USA LLC
Y 852.11
In Commercial Distribution

  • 00859982006360 ()
930400

  • Instrument tray, reusable
SILICONE MAT PERFORATED SM 225x235mm
BAHADIR USA LLC
Y852.01
In Commercial Distribution

  • 00859982006353 ()
920400

  • Instrument tray, reusable
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