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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
STRYKER CORPORATION
0894000002
In Commercial Distribution

  • 07613327622775 ()
0894-000-002

  • Blood weighing scale
AI Software
STRYKER CORPORATION
0894000001
In Commercial Distribution

  • 07613327622768 ()
0894-000-001

  • Blood loss estimation application software
Planning Software
Stryker Leibinger GmbH & Co. KG
8000-021-005
In Commercial Distribution

  • 07613327513950 ()
8000-021-005

  • Stereotactic system application software
ENT Software
Stryker Leibinger GmbH & Co. KG
8000-021-001
In Commercial Distribution

  • 07613327513943 ()
8000-021-001

  • Stereotactic system application software
Software Upgrade
LIGHTLAB IMAGING, INC.
Software Upgrade
In Commercial Distribution

  • 00812059021925 ()
E4-STD-WW

  • Coronary optical coherence tomography system
Software Upgrade
LIGHTLAB IMAGING, INC.
Metallic Stent Optimization Software
In Commercial Distribution

  • 00812059021918 ()
E4-FULL-WW

  • Coronary optical coherence tomography system
Playbook Software
ORTHOPEDIATRICS CORP.
PLAYBOOKMDDS
In Commercial Distribution

  • 00840194493871 ()
PLAYBOOKMDDS

  • Medical image management system
SentrySuite Software
Jaeger Medical GmbH
3.30
In Commercial Distribution

  • 04250892905945 ()
V-770968

  • Pulmonary function analysis system, adult
SentrySuite Software
Jaeger Medical GmbH
3.20
In Commercial Distribution

  • 04250892905891 ()
V-770965

  • Cardiopulmonary stress exercise monitoring system
SentrySuite Software
Jaeger Medical GmbH
3.10
In Commercial Distribution

  • 04250892905709 ()
V-770962-13

  • Pulmonary function analysis system, adult
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