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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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Dosing Set, 100µL
Gyroscope Usa, Inc.
PN1008927-001
In Commercial Distribution

  • 00850009362025 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
Tubing Set
Gyroscope Usa, Inc.
PN1008919-001
In Commercial Distribution

  • 00850009362018 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
Subretinal Injection Device Set
Gyroscope Usa, Inc.
PN1008904-001
In Commercial Distribution

  • 00850009362001 ()


  • Ophthalmic surgical procedure kit, non-medicated, single-use
A medical imaging software package that provides imaging solutions in the fields of radiation oncology, radiology, nuclear medicine, neuroimaging, and cardiac imaging.
MIM SOFTWARE INC.
7.4.70
In Commercial Distribution

  • 00850009343321 ()


  • Radiological PACS software
Contour ProtégéAI is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems. Contour ProtégéAI is deployed on a remote server using the MIMcloud service for data management and transfer; or locally on the workstation or server running MIM software.
MIM SOFTWARE INC.
1.3
In Commercial Distribution

  • 00850009343307 ()


  • Radiological PACS software
Contour ProtégéAI is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems. Contour ProtégéAI is deployed on a remote server using the MIMcloud service for data management and transfer; or locally on the workstation or server running MIM software.
MIM SOFTWARE INC.
1.2
In Commercial Distribution

  • 00850009343291 ()


  • Radiological PACS software
A medical imaging software package that provides imaging solutions in the fields of radiation oncology, radiology, nuclear medicine, neuroimaging, and cardiac imaging.
MIM SOFTWARE INC.
7.4
In Commercial Distribution

  • 00850009343284 ()


  • Radiological PACS software
A medical imaging software package that provides imaging solutions in the fields of radiation oncology, radiology, nuclear medicine, neuroimaging, and cardiac imaging.
MIM SOFTWARE INC.
7.3
In Commercial Distribution

  • 00850009343277 ()


  • Radiological PACS software
Contour ProtégéAI is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems. Contour ProtégéAI is deployed on a remote server using the MIMcloud service for data management and transfer; or locally on the workstation or server running MIM software.
MIM SOFTWARE INC.
1.0
In Commercial Distribution

  • 00850009343239 ()


  • Radiological PACS software
Contour ProtégéAI is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems. Contour ProtégéAI is deployed on a remote server using the MIMcloud service for data management and transfer; or locally on the workstation or server running MIM software.
MIM SOFTWARE INC.
2.0
In Commercial Distribution

  • 00850009343215 ()


  • Radiological PACS software
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