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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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OMNIBotics - 00841690194392

Software Package, ART Knee 2.7
Omni Life Science, Inc.
NS-27114
In Commercial Distribution

  • 00841690194392 ()
NS-27114

  • Robotic surgical navigation system application 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

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

not applicable - 00195278655141

Software Pristina 8.2 - ISO file
GE MEDICAL SYSTEMS
PRISTINA 2.8.2
In Commercial Distribution

  • 00195278655141 ()


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

not applicable - 00195278560049

Software Pristina 8.1 - ISO file
GE MEDICAL SYSTEMS
PRISTINA 2.8
In Commercial Distribution

  • 00195278560049 ()


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

EchoPAC - 00195278504302

MD EchoPAC Software Only v206
GE Vingmed Ultrasound AS
Software Only v206
In Commercial Distribution

  • 00195278504302 ()


  • Ultrasound imaging system application software

Orthex - 00841731118844

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

  • 00841731118844 ()


  • External orthopaedic fixation frame calculation software

NA - 00841983103636

HL-7 INTERFACE FOR NEUROWORKBENCH SOFTWARE
NIHON KOHDEN AMERICA, INC.
A/NWB-HL7CS
In Commercial Distribution

  • 00841983103636 ()
A/NWB-HL7CS

  • Medical networking interface unit

NA - 00841983102219

SOFTWARE, EVENT POTENTIAL FOR MEB-2300
NIHON KOHDEN AMERICA, INC.
QP-260BK
In Commercial Distribution

  • 00841983102219 ()
QP-260BK

  • Evoked-potential graphic recording system

Sleepware - 00606959004849

Sleepware G3 Software Package, English
Respironics, Inc.
3.8
In Commercial Distribution

  • 00606959004849 ()
1082462

  • Polysomnography analyser
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