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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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QBL Software License
STRYKER CORPORATION
0794111090
In Commercial Distribution

  • 07613327568998 ()
0794-111-090

  • Electronic surgical sponge-counter
Spine Guidance Software
Stryker Leibinger GmbH & Co. KG
6002-710-000
In Commercial Distribution

  • 07613327545883 ()
6002-710-000

  • Surgical planning/navigation-enhancement system
PROFESS(TM) SOFTWARE
Stryker Leibinger GmbH & Co. KG
6001-400-000
In Commercial Distribution

  • 07613327071948 ()
6001-400-000

  • Robotic surgical navigation system application software
SmartPill software v3.1
Given Imaging, Inc.
FGS-0658
In Commercial Distribution

  • 07290110360481 ()


  • Gastrointestinal telemetric monitoring system
Reflux software v6.1
Given Imaging, Inc.
FGS-0656
In Commercial Distribution

  • 07290110360429 ()


  • Gastrointestinal telemetric monitoring system
MyShoulder Planner Software
Medacta International SA
5.3SSWPL
In Commercial Distribution

  • 07630542730153 ()


  • Orthopaedic/craniofacial implantation planning software
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
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