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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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Sun Nuclear Phototimer Consistency Tools - B136159ABR0

No Description
SUN NUCLEAR CORP.
159ABR
In Commercial Distribution

  • B136159ABR0 ()


  • Mammographic x-ray phantom, test object

Phototimer Consistency Tools - B136159A0

No Description
SUN NUCLEAR CORP.
159A
In Commercial Distribution

  • B136159A0 ()


  • Mammographic x-ray phantom, test object

Instrumentation Difra - B51622092

The VIDEOSTAR is a digital videoscopy system. It is designed to allow qualified personnel to visualize eye reaction of the patient and record digital video. Freefield videonystagmoscope digital USB2
Instrumentation Difra SA
VIDEOSTAR II
In Commercial Distribution

  • B51622092 ()
22092

  • Posturography system platform

Instrumentation Difra - B51622090

The videonystagmoscope transcribes the image of the patient's eye on a computer screen. The VIDEOSTAR can thus assess the reactions of the patient viewing his nystagmus during testing positions, caloric, rotary or due to any other stimulus. The camera can be placed in front of the patient's right or left eye. The camera is fixed on a mask, fitting the line of the patient's face in order to occult completely from the outside light. The second eye view is either closed by an eyepiece or let free, which leaves it a free view. TECHNICAL SPECIFICATION: USB 2.0 connection 30 frames/s Resolution: 640 x 480 pixels Cable of 5 meters Compatible Windows Seven/8 - 32 or 64 bits
Instrumentation Difra SA
VIDEOSTAR
In Commercial Distribution

  • B51622090 ()
22090

  • Posturography system platform

NuVaMap - 00887517695505

NuVaMap O.R. Calibration Sphere
Nuvasive, Inc.
8210347
In Commercial Distribution

  • 00887517695505 ()


  • Spinal rod bending system

MyCareLink Smart™ - 00763000305079

MON 25000 MCL SMART 2.1 USA
MEDTRONIC, INC.
25000
Not in Commercial Distribution

  • 00763000305079 ()


  • Cardiac pulse generator reader, home-use

Navina™ Smart App for Android - 07333387030395

Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75751
In Commercial Distribution

75751

  • Rectal irrigation system application software

Navina™ Smart App for iOS - 07333387030388

Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75750
In Commercial Distribution

75750

  • Rectal irrigation system application software

NuVaMap - 00887517590268

NuVaMap O.R. Imaging Kit
Nuvasive, Inc.
2060040
In Commercial Distribution

  • 00887517590268 ()


  • Spinal rod bending system

Navina™ Smart App for Android - 07392532242380

Navina Smart Transanal Irrigation. Bowel diary APP
Wellspect AB
75751
Not in Commercial Distribution

  • 07392532242380 ()
75751

  • Rectal irrigation system application software
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