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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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SX-One MicroKnife is rebranded as UltraGuideCTR. UltraGuideCTR is intended to transect the transverse carpal ligament for the treatment of carpal tunnel syndrome. UltraGuideCTR is a disposable device intended to create space within the carpal tunnel and transect the transverse carpal ligament (TCL) for the treatment of carpal tunnel syndrome.
SONEX HEALTH, INC.
600112-001
In Commercial Distribution

  • 00860002094700 ()
  • 00860002094717 ()
600112-001

  • Hand ligament surgical release instrument
Radiation Shielding Panel, portal/mobile
Rampart Ic, LLC
M1128-RTV01
In Commercial Distribution

  • 00860002090108 ()


  • Radiation shielding panel, portable/mobile
Seven ovulation tests
Get Stix Inc.
1
In Commercial Distribution

  • 00860002060415 ()
  • 00850024942394 ()


  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Decorated Adhesive Bandages, assorted sizes, strips 0.75 IN x 3 IN (19 mm x 76 mm); circles 1.25 IN x 1.25 IN (31 mm x 31 mm)
Aso LLC
860001904314
Not in Commercial Distribution

  • 20860001904318 ()
  • 00860001904314 ()
  • 60860001904316 ()


  • Skin-cover adhesive strip, non-antimicrobial
Natalist Ovulation Test is a self-testing rapid chromatographic immunoassay for the qualitative detection of human luteinizing hormone (LH) in urine to predict the time of ovulation. There are 7pcs of 6mm midstreams in each box.
Equinox Biotech Co., Ltd.
82221
In Commercial Distribution

  • 00860001730210 ()
RH-LH-B

  • Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Virtual Field VF3 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 a color vision screening exam.
Field Virtual Inc
VF3
In Commercial Distribution

  • 00860001720433 ()
White

  • Perimeter, automatic
  • Colour discrimination tester
Virtual Field VF3 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 a color vision screening exam.
Field Virtual Inc
VF3
In Commercial Distribution

  • 00860001720426 ()
Dark Gray

  • Perimeter, automatic
  • Colour discrimination tester
Virtual Field 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. The Virtual Field Website is used to launch exams, view patient results, and manage account information.
Field Virtual Inc
VF Software
In Commercial Distribution

  • 00860001720419 ()
Release Version 2023.4.2

  • Pupillometer, electrically-powered
  • Perimeter, automatic
  • Colour discrimination tester
  • Pupillograph
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 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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