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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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Profile System; with ColorBurst is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-R-1-NNNN-2-N
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007059 ()


  • Electroretinograph
Profile System; with Xenon ColorDome on an Operating Room Arm is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-R-1-CDXR-N-N
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007042 ()


  • Electroretinograph
The Profile System; with Non-Xenon ColorDome on an Operating Room Arm is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). Configuration: D310-R-1-CDNR-N-N
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007035 ()


  • Electroretinograph
The Profle System with Xenon ColorDome & ColorBurst is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing, displaying, and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes). It's product configuration D310-R-1-CDXS-2-N.
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007028 ()


  • Electroretinograph
Standalone is a clinical and research visual electrophysiology system that functions by presenting a light stimulus to the eye, and then capturing displaying and storing the waveform of the electrical response from the retina (corneal electrode) or brain (occipital skin electrodes).
DIAGNOSYS LLC
D175
In Commercial Distribution

  • 00850594007004 ()


  • Electroretinograph
aScope 4 RhinoLaryngo Intervention
Ambu A/S
512101000
In Commercial Distribution

  • 05707480157785 ()
  • 05707480157778 ()
  • 05707480157761 ()

  • Lumen/Inner Diameter: 2 Millimeter
  • Outer Diameter: 5 Millimeter
  • Length: 350 Millimeter
512101000

  • Flexible video otorhinolaryngoscope, single-use
aScope 4 Cysto - Standard Deflection (20 pcs)
Ambu A/S
601005000
In Commercial Distribution

  • 05707480146338 ()
  • 05707480146345 ()
  • 05707480146321 ()

  • Outer Diameter: 6 Millimeter
  • Length: 390 Millimeter
  • Lumen/Inner Diameter: 2.2 Millimeter
601005000

  • Flexible video cystoscope, single-use
aScope 4 Cysto - Reverse Deflection (20 pcs)
Ambu A/S
600005000
In Commercial Distribution

  • 05707480146291 ()
  • 05707480146307 ()
  • 05707480146314 ()

  • Length: 390 Millimeter
  • Outer Diameter: 6 Millimeter
  • Lumen/Inner Diameter: 2.2 Millimeter
600005000

  • Flexible video cystoscope, single-use
aScope 4 RhinoLaryngo Slim (20 pcs)
Ambu A/S
510005000
In Commercial Distribution

  • 05707480146277 ()
  • 05707480146284 ()
  • 05707480146260 ()

  • Length: 300 Millimeter
  • Outer Diameter: 3 Millimeter
510005000

  • Flexible video otorhinolaryngoscope, single-use
aScope 4 Broncho Large Sampler Set
Ambu A/S
478501000
In Commercial Distribution

  • 05707480146000 ()
  • 05707480146017 ()
  • 05707480145997 ()

  • Lumen/Inner Diameter: 2.8 Millimeter
  • Outer Diameter: 5.8 Millimeter
  • Length: 600 Millimeter
478501000

  • Flexible video bronchoscope, single-use
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