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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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Cranial Guidance Software
Stryker Leibinger GmbH & Co. KG
6000-670-000
In Commercial Distribution

  • 07613327538298 ()
6000-670-000

  • Electromagnetic/optical surgical navigation device tracking system
Software Upgrade Kit
LIGHTLAB IMAGING, INC.
C.0.4 Software Upgrade
In Commercial Distribution

  • 00812059021536 ()
15211-01

  • Coronary optical coherence tomography system
Software Upgrade Kit
LIGHTLAB IMAGING, INC.
D.1 Software
In Commercial Distribution

  • 00812059021482 ()
100074942

  • Coronary optical coherence tomography system
Software Upgrade Kit
LIGHTLAB IMAGING, INC.
Integrated System E.2 Software
In Commercial Distribution

  • 00812059021390 ()
C408657

  • Coronary optical coherence tomography system
Software Upgrade Kit
LIGHTLAB IMAGING, INC.
OPTIS™ E.2 Software
In Commercial Distribution

  • 00812059021383 ()
C408656

  • Coronary optical coherence tomography system
Software Upgrade Kit
LIGHTLAB IMAGING, INC.
D.1.1 Software
In Commercial Distribution

  • 00812059020560 ()
100111860

  • Coronary optical coherence tomography system
FLUOROMAP 1.0 SOFTWARE
Stryker Leibinger GmbH & Co. KG
6006-600-000
In Commercial Distribution

  • 07613252286578 ()
6006-600-000

  • Robotic surgical navigation system application software
Cardiology Data Software
MORTARA INSTRUMENT, INC.
11049-010-51
In Commercial Distribution

  • 00812345025217 ()


  • Patient health record information system
Cardiology Data Software
MORTARA INSTRUMENT, INC.
11111-001-51    
In Commercial Distribution

  • 00812345024715 ()


  • Cardiology information system application software
Cardiology Data Software
MORTARA INSTRUMENT, INC.
11111-001-50    
In Commercial Distribution

  • 00812345024708 ()


  • Cardiology information system application software
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