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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Sleep Profiler PSG2 Device Kit - Piezo
ADVANCED BRAIN MONITORING, INC.
SP29-1006, SP29-1009
In Commercial Distribution

  • 00851113007154 ()
  • 00851113007291 ()


  • Home-use sleep apnoea recording system
  • Electroencephalograph
Sleep Profiler PSG2 Device kit - ezRIP
ADVANCED BRAIN MONITORING, INC.
SP29-1001, SP29-1008
In Commercial Distribution

  • 00851113007154 ()
  • 00851113007284 ()


  • Electroencephalograph
  • Home-use sleep apnoea recording system
Sleep Profiler PM3 Device Kit
ADVANCED BRAIN MONITORING, INC.
SP29-1002, SP29-1007
In Commercial Distribution

  • 00851113007154 ()
  • 00851113007277 ()


  • Electroencephalograph
  • Home-use sleep apnoea recording system
Laser Safety Sport Fit-Over Goggle, OD 5+ @ 800nm-820nm EN207: 800-820 DIR LB5 PF w/ Box and Lanyard
AMD Lasers
EYEF
Not in Commercial Distribution

  • 00851759007174 ()
EYEF

  • Radiation shielding goggles/spectacles
Laser Safety Sport Goggle, OD 5+ @ 800nm-820nm EN207: 800-820 DIR LB5 PF w/ Box and Lanyard
AMD Lasers
EYE
Not in Commercial Distribution

  • 00851759007167 ()
EYE

  • Radiation shielding goggles/spectacles
400um strippable fiber for use with the Picasso soft-tissue dental lasers. The strippable fiber has a black strain relief and an ST connection for legacy Picasso units.
AMD Lasers
SF400-ST
Not in Commercial Distribution

  • 00851759007150 ()
SF400-ST

  • Dental diode laser system
400um strippable fiber for use with the Picasso Plus or Picasso Lite Plus soft-tissue dental lasers. The strippable fiber has a blue strain relief.
AMD Lasers
SF400-PLUS
Not in Commercial Distribution

  • 00851759007143 ()
SF400-PLUS

  • Dental diode laser system
400um strippable fiber for use with the Picasso or Picasso Lite soft-tissue dental lasers. The strippable fiber has an orange strain relief and an FC connector.
AMD Lasers
SF400-FC
Not in Commercial Distribution

  • 00851759007136 ()
SF400-FC

  • Dental diode laser system
Multi-tip handpiece (MTHP) for use with the Picasso Lite soft-tissue dental laser. This multi-tip handpiece has an black jacket.
AMD Lasers
STF200
Not in Commercial Distribution

  • 00851759007129 ()
STF200

  • Dental diode laser system
Multi-tip handpiece (MTHP) for use with the Picasso soft-tissue dental laser. This multi-tip handpiece has an orange jacket.
AMD Lasers
STF400
Not in Commercial Distribution

  • 00851759007112 ()
STF400

  • Dental diode laser system
Quadra whitening tip for use with the the Picasso or Picasso Plus soft-tissue dental laser. Compatible with the multi-tip handpiece (MTHP).
AMD Lasers
QT
Not in Commercial Distribution

  • 00851759007105 ()
QT

  • Dental diode laser system
Multi-tip handpiece (MTHP) for use with the Picasso Lite Plus soft-tissue dental laser. This multi-tip handpiece has a black jacket.
AMD Lasers
MTHP-PLPLUS
Not in Commercial Distribution

  • 00851759007099 ()
MTHP-PLPLUS

  • Dental diode laser system
Multi-tip handpiece (MTHP) for use with the Picasso Plus soft-tissue dental laser. This multi-tip handpiece has an orange jacket.
AMD Lasers
MTHP-PPLUS
Not in Commercial Distribution

  • 00851759007082 ()
MTHP-PPLUS

  • Dental diode laser system
Picasso Lite Plus soft-tissue dental diode laser with wireless foot control. The laser has maximum power output of 3W and working beam wavelength of 810nm.
AMD Lasers
PL810
Not in Commercial Distribution

  • 00851759007013 ()
PLPLUS

  • Dental diode laser system
Picasso Plus soft-tissue dental diode laser with wireless foot control. The laser has maximum power output of 7W and working beam wavelength of 810nm.
AMD Lasers
P810
Not in Commercial Distribution

  • 00851759007006 ()
PPLUS

  • Dental diode laser system
Profile System; with ColorBurst and Mini OLED with extendable 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-G-1-NNNN-2-X
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007806 ()


  • Electroretinograph
Profile System; with Xenon ColorDome on an Operating Room Arm and Mini OLED with extendable 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-G-1-CDXR-N-X
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007790 ()


  • Electroretinograph
Profile System; with Non-Xenon ColorDome on an Operating Room Arm and Mini OLED with extendable 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-G-1-CDNR-N-X
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007783 ()


  • Electroretinograph
Profile System; with Xenon ColorDome and Mini OLED with extendable 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-G-1-CDXS-N-X
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007776 ()


  • Electroretinograph
Profile System; with Non-Xenon ColorDome and Mini OLED with extendable arm with table stand 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-G-1-CDNS-N-X
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007769 ()


  • Electroretinograph
E3 System; with Mini OLED and no computer 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: D315-6-1-NN
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00850594007752 ()


  • Electroretinograph
E3 System; with Mini OLED and Desktop Computer 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: D315-6-1-23
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00850594007745 ()


  • Electroretinograph
E3 System; with Mini OLED and Tablet Computer 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: D315-6-1-P
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00850594007738 ()


  • Electroretinograph
E3 System; with Non-Xenon ColorDome on an OR Stand and Mini OLED with table stand 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: D315-1-1-CDNRL-NN-N-T
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00850594007707 ()


  • Electroretinograph
E3 System; with Non-Xenon ColorDome on an OR Stand and ColorBurst and Mini OLED with table stand 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: D315-1-1-CDNRL-NN-2-T
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00850594007691 ()


  • Electroretinograph
E3 System; with Non-Xenon ColorDome on an OR Stand and 23" Monitor and ColorBurst and Mini OLED with table stand 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: D315-1-1-CDNRL-23-2-T
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00850594007684 ()


  • Electroretinograph
E3 System; with Non-Xenon ColorDome on an OR Stand and 23" Monitor and 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: D315-1-1-CDNRL-23-2-N
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00850594007677 ()


  • Electroretinograph
E3 System; with Non-Xenon ColorDome on an OR Stand and 23" Monitor 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: D315-1-1-CDNRL-23-N-N
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00850594007660 ()


  • Electroretinograph
E3 System; with Xenon ColorDome on an OR Stand and Mini OLED with table stand 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: D315-1-1-CDXRL-NN-N-T
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00850594007653 ()


  • Electroretinograph
E3 System; with Xenon ColorDome on an OR Stand and 23" Monitor and ColorBurst and Mini OLED with table stand 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: D315-1-1-CDXRL-23-2-T
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00850594007639 ()


  • Electroretinograph
E3 System; with Xenon ColorDome on an OR Stand and 23" Monitor and 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: D315-1-1-CDXRL-23-2-N
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00850594007622 ()


  • Electroretinograph
E3 System; with Non-Xenon ColorDome and ColorBurst and Mini OLED with table stand 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: D315-1-1-CDNSL-NN-2-T
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00850594007592 ()


  • Electroretinograph
Profile System; with Non-Xenon ColorDome on OR Arm and Mini OLED with table stand 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-G-1-CDNR-N-T
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007271 ()


  • Electroretinograph
Profile System; with Non-Xenon ColorDome and Mini OLED with table stand 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-G-1-CDNS-N-T
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007257 ()


  • Electroretinograph
Profile System; with Xenon ColorDome on an OR Arm and 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-CDXR-2-N
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007240 ()


  • Electroretinograph
Profile System; with Non-Xenon ColorDome on OR Arm and 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-CDNR-2-N
DIAGNOSYS LLC
D310
In Commercial Distribution

  • 00850594007233 ()


  • Electroretinograph
E3 Console Only: 220V 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: D315-4-2
DIAGNOSYS LLC
D315
In Commercial Distribution

  • 00850594007219 ()


  • 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
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
EndoSound Ultrasound Transducer Module (UTM) converts the electrical signals from the EVSScanner into ultrasound energy.
Endosound, Inc.
5016
In Commercial Distribution

  • 00850050934165 ()
5016

  • Flexible endoscopic ultrasound imaging transducer
The EndoSound Vision System (EVS) Software is the Microsoft Windows-based software run on a PC that processes the ultrasound data received from the EVSScanner module and displays the ultrasound image on the PC's monitor.
Endosound, Inc.
5011
In Commercial Distribution

  • 00850050934127 ()
5011

  • General-purpose ultrasound imaging system
The EndoSound Air Leak Tester is used with a UTM and pressure test cap to test the integrity of the UTM cable.
Endosound, Inc.
5030
In Commercial Distribution

  • 00850050934110 ()
5030

  • Invasive medical device leak tester, mechanical
EndoSound Vision System (EVS) UDK-T is a disposable, single-use sterile kit that is used to attach the UTM to the compatible endoscope and provide transducer and needle articulation. Sleeve Size: Inner Diameter: 9.3mm Wall Thickness: 0.7mm
Endosound, Inc.
5008
In Commercial Distribution

  • 00850050934103 ()
  • 00850050934066 ()

  • Lumen/Inner Diameter: 9.3 Millimeter
  • .7mm wall thickness
5007

  • General-purpose ultrasound imaging system
EndoSound Vision System (EVS) UDK-T is a disposable, single-use sterile kit that is used to attach the UTM to the compatible endoscope and provide transducer and needle articulation. Sleeve Size: Inner Diameter: 9.5mm Wall Thickness: 1.25mm
Endosound, Inc.
5010
In Commercial Distribution

  • 00850050934097 ()
  • 00850050934059 ()

  • Lumen/Inner Diameter: 9.5 Millimeter
  • 1.25mm wall thickness
5009

  • General-purpose ultrasound imaging system
EndoSound Vision System (EVS) UDK-T is a disposable, single-use sterile kit that is used to attach the UTM to the compatible endoscope and provide transducer and needle articulation. UDK Sleeve Size: Inner Diameter: 9mm Wall Thickness: 1mm
Endosound, Inc.
5006
In Commercial Distribution

  • 00850050934080 ()
  • 00850050934073 ()

  • Lumen/Inner Diameter: 9 Millimeter
  • 1mm wall thickness
5005

  • General-purpose ultrasound imaging system
EndoSound Vision System (EVS) UDK-T is a disposable, single-use sterile kit that is used to attach the UTM to the compatible endoscope and provide transducer and needle articulation. UDK Sleeve Size: Inner Diameter: 10.5mm Wall Thickness: 0.5mm
Endosound, Inc.
5004
In Commercial Distribution

  • 00850050934042 ()
  • 00850050934004 ()

  • Lumen/Inner Diameter: 10.5 Millimeter
  • .5mm wall thickness
5003

  • General-purpose ultrasound imaging system
EndoSound Ultrasound Transducer Module (UTM) converts the electrical signals from the EVSScanner into ultrasound energy.
Endosound, Inc.
5001
In Commercial Distribution

  • 00850050934035 ()
5001

  • Flexible endoscopic ultrasound imaging transducer
The EndoSound Vision System (EVS) Scanner is a small, portable, self-contained module that contains the electronics that perform ultrasound scanning and receiving functions (beamforming).
Endosound, Inc.
5000
In Commercial Distribution

  • 00850050934028 ()
5000

  • General-purpose ultrasound imaging system
The EndoSound Transducer Extension Connector (TEC) includes the electrical connectors and cable between the EVSScanner and the UTM.
Endosound, Inc.
5002
In Commercial Distribution

  • 00850050934011 ()
5002

  • General-purpose ultrasound imaging system
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