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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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VF3 Pro is a portable virtual reality visual field device. It runs a variety of visual field patterns, including but not limited to 10-2, 24-2, and 30-2, as well as multiple strategies, from suprathreshold screenings to full threshold tests. It also includes eye tracking capabilities, a color vision screening exam, and a pupillometer exam.
Field Virtual Inc
VF3 Pro
In Commercial Distribution

  • 00860001720402 ()


  • Pupillometer, electrically-powered
  • Perimeter, automatic
  • Colour discrimination tester
  • Pupillograph
The Move-D device is a lightweight, easy-to-wear, portable and comfortable orthosis designed to minimize tremors in the dominant upper extremity for patients with movement disorders.
INNOVATION INSTITUTE, LLC
3626-90001
In Commercial Distribution

  • 00860001704877 ()


  • Elbow orthosis
PharmChem, Inc. Transparent Overlay Film (4" x 5") with Cutout (1" x 1.65").
PHARMCHEM, INC.
Single Overlay - Rev. 3
In Commercial Distribution

  • 00860002279626 ()
  • 00860001701098 ()
  • 10860002279623 ()


  • Adhesive bandage
PharmChem, Inc. Transparent Overlay Film (4" x 5") with Cutout (1" x 1.65").
PHARMCHEM, INC.
Single Overlay
In Commercial Distribution

  • 10860001701064 ()
  • 00860001701067 ()
  • 00860001701012 ()


  • Adhesive bandage
PharmChek® is a drug sweat patch worn on the skin surface for up to 10 days or longer that acts as a specimen container for the non-volatile and liquid components of sweat.
PHARMCHEM, INC.
Single Patch
In Commercial Distribution

  • 00860001701005 ()
  • 00860001701029 ()
  • 10860001701026 ()
  • 20860001701023 ()
  • 00860001701036 ()
  • 10860001701033 ()


  • Drug-testing specimen collection kit IVD
The "Protect-A-Grid" line of Premium Grid Encasements house x-ray grids in either Polycarbonate or Aluminum shells. They may also be used with 14x17” film or CR cassettes. They house an x-ray grid to be used in general radiography. Their secondary purpose is to hold a DR Panel during exams. "
Reina Imaging
P[2][X]DR[NG][Y]
In Commercial Distribution

  • 00860001700183 ()
Premium Grid Encasement

  • Stationary x-ray grid
Protect Grid and Image Receptor from Weight Bearing damage and position patient relative to Image Receptor
Reina Imaging
WDDR[X]
In Commercial Distribution

  • 00860001700176 ()


  • Footstool
  • Flat panel x-ray detector/film cassette weight-bearing protector
Designed as a patient stabilizer for use when taking a radiograph requiring stitching software. The device provides a stepping platform for the patient and a clear polycarbonate back that allows a radiology technologist to position the device centered to the image receptor, facilitating patient positioning.
Reina Imaging
CSS[X]; SPH-F
In Commercial Distribution

  • 00860001700169 ()


  • Radiological general body-part positioner
Device is a holder for digital detectors(DR Panels). It is used to hold digital detectors in place during radiographic exam. It allows for multiple orientations of the DR panel and features wheels for mobility
Reina Imaging
[T][#]-[Z]
In Commercial Distribution

  • 00860001700121 ()
Digital Detector Holder

  • X-ray film cassette holder
The Collim-Aid fits onto the collimator, shielding the patient, the operator, or other persons from unnecessary exposure to radiation during radiologic procedures by providing an attenuating barrier to radiation.
Reina Imaging
CA2
In Commercial Distribution

  • 00860001700107 ()


  • Radiation shielding panel, portable/mobile
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