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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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Ponto 3 SuperPower, L, PUW
Oticon Medical AB
M52658
In Commercial Distribution

  • 05712149011926 ()
M52658

  • Anchored bone-conduction hearing implant system
Ponto 3 SuperPower, R, STG
Oticon Medical AB
M52657
In Commercial Distribution

  • 05712149011919 ()
M52657

  • Anchored bone-conduction hearing implant system
Ponto 3 SuperPower, L, STG
Oticon Medical AB
M52656
In Commercial Distribution

  • 05712149011902 ()
M52656

  • Anchored bone-conduction hearing implant system
Ponto 3 SuperPower, R, WHS
Oticon Medical AB
M52655
In Commercial Distribution

  • 05712149011896 ()
M52655

  • Anchored bone-conduction hearing implant system
Ponto 3 SuperPower, L, WHS
Oticon Medical AB
M52654
In Commercial Distribution

  • 05712149011889 ()
M52654

  • Anchored bone-conduction hearing implant system
Ponto 3 SuperPower, R, CBE
Oticon Medical AB
M52653
In Commercial Distribution

  • 05712149011872 ()
M52653

  • Anchored bone-conduction hearing implant system
Ponto 3 SuperPower, L, CBE
Oticon Medical AB
M52652
In Commercial Distribution

  • 05712149011865 ()
M52652

  • Anchored bone-conduction hearing implant system
Ponto 3 SuperPower, R, MBR
Oticon Medical AB
M52651
In Commercial Distribution

  • 05712149011858 ()
M52651

  • Anchored bone-conduction hearing implant system
Ponto 3 SuperPower, L, MBR
Oticon Medical AB
M52650
In Commercial Distribution

  • 05712149011841 ()
M52650

  • Anchored bone-conduction hearing implant system
Ponto 3 SuperPower, R, DBL
Oticon Medical AB
M52649
In Commercial Distribution

  • 05712149011834 ()
M52649

  • Anchored bone-conduction hearing implant system
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
Implant, 3 mm, with abutment, 6 mm
Oticon Medical AB
M50784
Not in Commercial Distribution

  • 05712149002436 ()

  • Length: 6 Millimeter
  • Outer Diameter: 3.75 Millimeter
  • Length: 3 Millimeter
M50784

  • Craniofacial bone screw, non-bioabsorbable
Soft band, red, bilateral
Oticon Medical AB
M50739
In Commercial Distribution

  • 05712149002207 ()
M50739

  • Head-worn bone-conduction hearing aid
Soft band, navy blue, bilateral
Oticon Medical AB
M50738
In Commercial Distribution

  • 05712149002191 ()
M50738

  • Head-worn bone-conduction hearing aid
Soft band, beige, bilateral
Oticon Medical AB
M50737
In Commercial Distribution

  • 05712149002184 ()
M50737

  • Head-worn bone-conduction hearing aid
Soft band, black, bilateral
Oticon Medical AB
M50736
In Commercial Distribution

  • 05712149002177 ()
M50736

  • Head-worn bone-conduction hearing aid
Soft band, light blue, bilateral
Oticon Medical AB
M50735
In Commercial Distribution

  • 05712149002160 ()
M50735

  • Head-worn bone-conduction hearing aid
Soft band, pink, bilateral
Oticon Medical AB
M50734
In Commercial Distribution

  • 05712149002153 ()
M50734

  • Head-worn bone-conduction hearing aid
Ponto Pro Power, left, diamond black
Oticon Medical AB
M50677
Not in Commercial Distribution

  • 05712149001910 ()
M50677

  • Anchored bone-conduction hearing implant system
Ponto Pro Power, right, diamond black
Oticon Medical AB
M50676
Not in Commercial Distribution

  • 05712149001903 ()
M50676

  • Anchored bone-conduction hearing implant system
Soft band, red
Oticon Medical AB
M50640
In Commercial Distribution

  • 05712149001774 ()
M50640

  • Head-worn bone-conduction hearing aid
Soft band, navy blue
Oticon Medical AB
M50639
In Commercial Distribution

  • 05712149001767 ()
M50639

  • Head-worn bone-conduction hearing aid
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