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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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not applicable - 00195278716026

UDI Software Pristina ME 9.1
GE MEDICAL SYSTEMS
PRISTINA ME 9.1
In Commercial Distribution

  • 00195278716026 ()


  • Mammographic x-ray system stereotactic unit
  • Stationary mammographic x-ray system, digital

CIOS SELECT - 04056869267197

mobile C-arm; software version VA21
Siemens Shanghai Medical Equipment Ltd.
11515055
In Commercial Distribution

  • 04056869267197 ()


  • Portable general-purpose fluoroscopic x-ray system, analogue

Cios Spin - 04056869153506

mobile C-arm; software version VA30
Siemens Healthcare GmbH
10308194
In Commercial Distribution

  • 04056869153506 ()


  • Portable general-purpose fluoroscopic x-ray system, digital

Cios Alpha - 04056869153490

mobile C-arm; software version VA30
Siemens Healthcare GmbH
11105200
In Commercial Distribution

  • 04056869153490 ()


  • Portable general-purpose fluoroscopic x-ray system, digital

Cios Flow - 04056869246628

mobile C-arm; software version VA30
Siemens Healthcare GmbH
11108110
In Commercial Distribution

  • 04056869246628 ()


  • Portable general-purpose fluoroscopic x-ray system, digital

Orthex - 00841731118844

Orthex P&C Software v1.2
VILEX IN TENNESSEE, INC.
ORTHEXRPS
In Commercial Distribution

  • 00841731118844 ()


  • External orthopaedic fixation frame calculation software

OMNIBotics - 00841690194712

ART Knee Software unitary component
Omni Life Science, Inc.
0770-2000
In Commercial Distribution

  • 00841690194712 ()
0770-2000

  • Robotic surgical navigation system application software

OMNIBotics - 00841690194460

ART Knee Software Rev 2.4.0
Omni Life Science, Inc.
NS-27014
In Commercial Distribution

  • 00841690194460 ()
NS-27014

  • Robotic surgical navigation system application software

OMNIBotics - 00841690194446

ART Knee Software Rev 2.5.0
Omni Life Science, Inc.
NS-27016
In Commercial Distribution

  • 00841690194446 ()
NS-27016

  • Robotic surgical navigation system application software

OMNIBotics - 00841690194439

ART Knee Software Rev 2.6.0
Omni Life Science, Inc.
NS-27017
In Commercial Distribution

  • 00841690194439 ()
NS-27017

  • Robotic surgical navigation system application software
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