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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 Class Implantable

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Oscilla - 05713557000014

No Description
Inmedico A/S
SM910
Not in Commercial Distribution

  • 05713557000014 ()


  • Tone audiometer
  • Tone audiometer, manual

StitchKit - 00860088000206

StitchKit ePTFE Suture Delivery Canister
ORIGAMI SURGICAL LLC
SK-002
In Commercial Distribution

  • 00860088000206 ()
  • 00860088000213 ()


  • Polytetrafluoroethylene suture

Dymaxeon - 00815500025008

DYMAXEON SPONDYLOLISTHESIS PEDICLE SCREW - CAP INCLUDED SIZE Ø6.5 x 60mm (GREEN)
BACK 2 BASIC DIRECT, LLC
06.0
In Commercial Distribution

  • 00815500025008 ()
06.3860B-1

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon - 00815500024476

DYMAXEON PEDICLE SCREW - CANNULATED - CAP INCLUDED Ø7.5 x 35mm (VIOLET)
BACK 2 BASIC DIRECT, LLC
05.5
In Commercial Distribution

  • 00815500024476 ()
06.6600B-1

  • Bone-screw internal spinal fixation system, sterile

Norav 1200 Series PC-ECG - 07290110255411

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - I3 = Resting-ECG Measurement and MEANS Analysis ECG Measurements & Expert System, The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW I3
In Commercial Distribution

  • 07290110255411 ()
HASP-SW-K-I3-01

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

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 - 07290110252601

Norav 1200 Series PC-ECG Software Kit (COSMED) with the following Option(s): - D1 = ECG Management System NEMS - S2 = Advanced Stress-Test ECG - 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-D1
In Commercial Distribution

  • 07290110252601 ()
HASP-SW-K-S2I2D1-01

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

Norav 1200 Series PC-ECG - 07290110252816

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 - I3 = Resting-ECG Measurement and Interpretation MEANS (Uni. of Rotterdam, NL) - D1 = Norav ECG Management System NEMS The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2-I3-D1
In Commercial Distribution

  • 07290110252816 ()
HASP-SW-K-S2I3D1-01

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

Norav 1200 Series PC-ECG - 07290110252809

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 = Resting-ECG Measurement - D1 = Norav ECG Management System NEMS The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW S2-I1-D1
In Commercial Distribution

  • 07290110252809 ()
HASP-SW-K-S2I1D1-01

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

Norav 1200 Series PC-ECG - 07290110252632

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - 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 I2
In Commercial Distribution

  • 07290110252632 ()
HASP-SW-K-I2-01

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