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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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No Description
LINKVERSE SRL
GGM100.US
In Commercial Distribution

  • 08055060110314 ()


  • Endoscopic video image interpretive unit
No Description
LINKVERSE SRL
CPRO40.US
In Commercial Distribution

  • 78055060110290 ()
  • 08055060110291 ()


  • Endoscopic video image interpretive software
No Description
LINKVERSE SRL
Accessory to GI Genius
In Commercial Distribution

  • 08055060110185 ()
FS01

  • Foot-switch, electrical
No Description
LINKVERSE SRL
Accessory to GI Genius
In Commercial Distribution

  • 08055060110178 ()
UKS01

  • Foot-switch, electrical
No Description
LINKVERSE SRL
4.0.1-S
In Commercial Distribution

  • 78055060110375 ()
  • 08055060110376 ()
CPRO401S-US

  • Endoscopic video image interpretive software
Software to be used in GI Genius™ systems.
LINKVERSE SRL
4.0.1
In Commercial Distribution

  • 78055060110344 ()
  • 08055060110345 ()
CPRO401-US

  • Endoscopic video image interpretive software
GI Genius™ system with software ColonPRO™.
LINKVERSE SRL
GGM300-US
In Commercial Distribution

  • 08055060110338 ()


  • Endoscopic video image interpretive unit
No Description
LINKVERSE SRL
GGM200.US
In Commercial Distribution

  • 08055060110321 ()


  • Endoscopic video image interpretive unit
This Software as a Medical Device provides a user with automatic contouring of delayed enhancement and ejection fractions studies. Ejection fraction studies are segmented in short axis views for verification and accuracy.
Terarecon Inc.
Cardiac.Chambers.MR01
In Commercial Distribution

  • CARDIACCHAMBERSMR1 ()
CARDIACCHAMBERSMR1

  • Radiology DICOM image processing application software
No Description
EOS IMAGING
2.1
In Commercial Distribution

  • 03663999000337 ()


  • Basic diagnostic x-ray system application software
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