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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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This condom is made of a natural latex sheath, which completely covers the erect penis with a closely fitted membrane. This condom is straight-walled with a reservoir tip; nominal length 180 mm, nominal width 52 mm, and nominal thickness 0.045mm. It is lubricated with silicone and cornstarch is used as a dressing material. This condom is designed to conform to established national and international voluntary standards including ASTM D3492 and IS0 407. The condom is used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted infections.
ISSAWRAP INC
Exceptionally Thin Latex Condoms
In Commercial Distribution

  • 00860001852400 ()
  • 00860001852417 ()


  • Basic male condom, Hevea-latex
Education Unit for Movive
Medrhythms, Inc.
005EDU
In Commercial Distribution

  • 00860001790832 ()


  • Neuromuscular rehabilitation software
Education Unit for InTandem
Medrhythms, Inc.
001EDU
In Commercial Distribution

  • 00860001790825 ()


  • Neuromuscular rehabilitation software
Movive is indicated to support gait rehabilitation and motor function for people living with Parkinson's disease. Movive is intended to be used in the home for the physical rehabilitation of ambulatory adults with walking impairments from Parkinson's disease.
Medrhythms, Inc.
0050
In Commercial Distribution

  • 00860001790818 ()


  • Neuromuscular rehabilitation software
InTandem is indicated to improve walking and ambulation in adult chronic stroke patients. InTandem is intended to be used in the home for the physical rehabilitation of ambulatory adults with chronic stroke walking impairments.
Medrhythms, Inc.
0010
In Commercial Distribution

  • 00860001790801 ()


  • Neuromuscular rehabilitation software
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
Natalist Pregnancy Test is intended for the qualitative determination of human chorionic gonadotropin (hCG) in the urine to aid in early detection of pregnancy. There are 3 6mm midstreams in one box.
Equinox Biotech Co., Ltd.
82214
In Commercial Distribution

  • 00860001730203 ()


  • Total human chorionic gonadotropin 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
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