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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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Mobius3D - 00861334000315

Secondary Check QA Software
VARIAN MEDICAL SYSTEMS, INC.
2.0.1
Not in Commercial Distribution

  • 00861334000315 ()
Mobius3D

  • Accelerator system quality assurance device

n.a. - 04048551392270

SCB control NEO Software
Karl Storz GmbH & Co. KG
20090001-47
In Commercial Distribution

  • 04048551392270 ()


  • Operating room audiovisual data/device management system application software

AESCULAP - 04046963492083

ORTHOPILOT SOFTWARE COLUMBUS TKR
Aesculap AG
FS222
Not in Commercial Distribution

  • 04046963492083 ()
FS222

  • Robotic surgical navigation system application software

Spine & Trauma 3D Navigation - 04056481142025

Software for spine navigation
Brainlab AG
1,5
In Commercial Distribution

  • 04056481142025 ()


  • Robotic surgical navigation system

AESCULAP - 04046963989101

ORTHOPILOT SOFTWARE THA ACA
Aesculap AG
FS229
Not in Commercial Distribution

  • 04046963989101 ()
FS229

  • Robotic surgical navigation system application software

AESCULAP - 04046963977979

ORTHOPILOT SOFTWARE TKA SMART
Aesculap AG
FS228
Not in Commercial Distribution

  • 04046963977979 ()
FS228

  • Robotic surgical navigation system application software

AESCULAP - 04046963895853

ORTHOPILOT SOFTWARE TKA VEGA
Aesculap AG
FS226
Not in Commercial Distribution

  • 04046963895853 ()
FS226

  • Robotic surgical navigation system application software

TRUEmanager - 00021292008666

TRUEmanager Diabetes Management Software
TRIVIDIA HEALTH, INC.
TRUEmanager Diabetes Management Software
In Commercial Distribution

  • 00021292008666 ()
RM9NPD78

  • Self-care monitoring/reporting software

SpecialsLab - 00840682123587

SOFTWARE SPECIALSLAB V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
Not in Commercial Distribution

  • 00840682123587 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system

ComboLab - 00840682123570

SOFTWARE COMBOLAB V6.9.6 R3
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
v6.9.6 R3
In Commercial Distribution

  • 00840682123570 ()


  • Cardiac catheterization monitoring system
  • Cardiac electrophysiology analysis system
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