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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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CD HORIZON® SOLERA® Spinal System - 00763000213558

ROD 654700045 5.5 TI AL PERC ROD 45MM S
MEDTRONIC SOFAMOR DANEK, INC.
654700045
Not in Commercial Distribution

  • 00763000213558 ()


  • Bone-screw internal spinal fixation system, sterile

CD HORIZON® SOLERA® Spinal System - 00763000213541

ROD 654700040 5.5 TI AL PERC ROD 40MM S
MEDTRONIC SOFAMOR DANEK, INC.
654700040
Not in Commercial Distribution

  • 00763000213541 ()


  • Bone-screw internal spinal fixation system, sterile

CD HORIZON® SOLERA® Spinal System - 00763000213534

ROD 654700035 5.5 TI AL PERC ROD 35MM S
MEDTRONIC SOFAMOR DANEK, INC.
654700035
Not in Commercial Distribution

  • 00763000213534 ()


  • Bone-screw internal spinal fixation system, sterile

CD HORIZON® SOLERA® Spinal System - 00763000213527

ROD 654700030 5.5 TI AL PERC ROD 30MM S
MEDTRONIC SOFAMOR DANEK, INC.
654700030
Not in Commercial Distribution

  • 00763000213527 ()


  • Bone-screw internal spinal fixation system, sterile

Norav 1200 Series PC-ECG - 07290110255022

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer) - S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools - I2 = Resting-ECG Measurement and Advanced Interpretation The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2-I2
In Commercial Distribution

  • 07290110255022 ()
HASP-SW-K-S2I2-01

  • Patient-administration information system application software
  • Cardiovascular risk evaluation interpretive software
  • Cardiopulmonary stress exercise monitoring system computer

Norav 1200 Series PC-ECG - 07290110252793

Norav 1200 Series PC-ECG Software Kit for COSMED with the following Option(s): - S1 = Stress-Test ECG, including control of Exercise Devices (Treadmills, Ergometer) - S2 = Advanced Stress-Test ECG, including ST-Measurement and advanced Reporting Tools - I1 = Restin-ECG Measurement The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2-I1
In Commercial Distribution

  • 07290110252793 ()
HASP-SW-K-S2I1-01

  • Cardiovascular risk evaluation interpretive software
  • Cardiopulmonary stress exercise monitoring system computer

CD HORIZON® SOLERA® VOYAGER™ Spinal System - 00643169784550

SCREW 55850017080 5.5 VOYAGER MAS 7.0X80
MEDTRONIC SOFAMOR DANEK, INC.
55850017080
Not in Commercial Distribution

  • 00643169784550 ()

  • Outer Diameter: 7.0 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

CD HORIZON® SOLERA® VOYAGER™ Spinal System - 00643169784543

SCREW 55850017075 5.5 VOYAGER MAS 7.0X75
MEDTRONIC SOFAMOR DANEK, INC.
55850017075
Not in Commercial Distribution

  • 00643169784543 ()

  • Outer Diameter: 7.0 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

CD HORIZON® SOLERA® VOYAGER™ Spinal System - 00643169784536

SCREW 55850017070 5.5 VOYAGER MAS 7.0X70
MEDTRONIC SOFAMOR DANEK, INC.
55850017070
Not in Commercial Distribution

  • 00643169784536 ()

  • Outer Diameter: 7.0 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile

CD HORIZON® SOLERA® VOYAGER™ Spinal System - 00643169784529

SCREW 55850017065 5.5 VOYAGER MAS 7.0X65
MEDTRONIC SOFAMOR DANEK, INC.
55850017065
Not in Commercial Distribution

  • 00643169784529 ()

  • Outer Diameter: 7.0 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
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