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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ROD X0409282 6.35X80MM PK LINED
MEDTRONIC SOFAMOR DANEK, INC.
X0409282
Not in Commercial Distribution

  • 00613994664198 ()

  • Length: 80.0 Millimeter
  • Outer Diameter: 6.35 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
ROD X0409283 6.35X85MM PK LINED
MEDTRONIC SOFAMOR DANEK, INC.
X0409283
Not in Commercial Distribution

  • 00613994664181 ()

  • Outer Diameter: 6.35 Millimeter
  • Length: 85.0 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
ROD X0409284 6.35X90MM PK LINED
MEDTRONIC SOFAMOR DANEK, INC.
X0409284
Not in Commercial Distribution

  • 00613994664174 ()

  • Outer Diameter: 6.35 Millimeter
  • Length: 90.0 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
ROD X0409285 6.35X95MM PK LINED
MEDTRONIC SOFAMOR DANEK, INC.
X0409285
Not in Commercial Distribution

  • 00613994664167 ()

  • Length: 95.0 Millimeter
  • Outer Diameter: 6.35 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
ROD X0409286 6.35X100MM PK LINED
MEDTRONIC SOFAMOR DANEK, INC.
X0409286
Not in Commercial Distribution

  • 00613994664150 ()

  • Outer Diameter: 6.35 Millimeter
  • Length: 100.0 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
ROD X0409287 6.35X105MM PK LINED
MEDTRONIC SOFAMOR DANEK, INC.
X0409287
Not in Commercial Distribution

  • 00613994664143 ()

  • Length: 105.0 Millimeter
  • Outer Diameter: 6.35 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
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
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
The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It measures these necessary values successively through a non-contact optical measurement method. An optional A-scan probe is also available to scan axial length with an ultrasonic measurement function by touching it to the cornea should optical measurement not be successful. In addition, an anterior eye segment image overlaid with the corneal meridians can be created as a reference for toric IOL implantation. The AL-Scan also has the function to calculate the power of an IOL using measured values such as axial length.
NIDEK CO.,LTD.
AL-Scan
In Commercial Distribution

  • 04987669100547 ()


  • Optical pachymeter
  • Ophthalmic examination slit lamp
  • Bench-top keratometer
  • Ophthalmic ultrasound imaging system
Norav 1200 Series PC-ECG Software Kit with the following Option(s): - I3 = Resting-ECG Measurement and Interpretation MEANS (Univ. of Rotterdam, NL) - Network Capability for I3 The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW I3-N
In Commercial Distribution

  • 07290110255015 ()
HASP-SW-K-I3-N-02

  • Cardiovascular risk evaluation interpretive software
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