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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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The MyoPro 2+, an upper extremity limb orthosis, is an assistive device that supports a weakened or deformed limb for functional improvement. The user’s electromyography (EMG) muscle activity is used to voluntarily control the impaired limb. The MyoPro 2+ consists of a combination of the following components: a shoulder harness, a custom-made upper limb orthosis (brace), a powered elbow orthosis with surface electromyography (EMG) sensors, a static or manually set wrist module, a static hand orthosis or powered hand orthosis with EMG sensors, and an interchangeable battery with a separate recharging station. The MyoPro 2+ EMG-control circuit continuously monitors and senses, but does not stimulate, the User’s muscles. The MyoPro 2+ filters and processes the EMG signal, and translates this information into motor movement. Based on the User’s needs and abilities, the control parameters are adjusted by the User’s Provider. The power assist moves the motor with speed proportional to User’s exertion. This system enables the MyoPro 2+ to assist the User to initiate and complete desired motions.
Myomo, Inc.
Motion W Left - 28460 rev1
In Commercial Distribution

  • 00855846007139 ()
28460

  • Psychophysiological biofeedback system
  • Elbow orthosis
  • Hand orthosis
A non-sterile electrical conductor intended to be applied adjacent to the eye to transmit an electrical signal during an evaluation of the eye's retina. It is typically in the form of a conductive thread that is laid along the lower eyelid in contact with the tear film and cornea and connected to gold pins. The general device that records this electrical activity is the electroretinograph (ERG). This is a single-use device.
DIAGNOSYS LLC
D141
In Commercial Distribution

  • 10855730007426 ()
  • 00855730007429 ()
D141

  • Electroretinograph electrode
No Description
QARDIO, INC.
B200
In Commercial Distribution

  • 10854894005248 ()
  • 00854894005241 ()
B200-IAW

  • Bioelectrical body composition analyser
No Description
QARDIO, INC.
B200
In Commercial Distribution

  • 10854894005231 ()
  • 00854894005234 ()
B200-IVB

  • Bioelectrical body composition analyser
ANTI-CCP/2 ANTIBODY ELISA TEST KIT, 192 TESTS
THERA-TEST LABORATORIES, INC
104-122
In Commercial Distribution

  • 00854473003019 ()
104-122

  • Cyclic citrullinated peptide antibody (anti-CCP) IVD, kit, enzyme immunoassay (EIA)
Large-area handheld skin exam light (polarized & 3 UV wavelenghts)
DermLite LLC
DLU2
In Commercial Distribution

  • 00855997006722 ()
DLU2

  • Dermatoscope, optical
Elevating Radiographic Table
CONTROL-X Medical Kereskedelmi és Szolgáltató Zártkörűen Működő Részvénytársaság
PHX2
Not in Commercial Distribution

  • 05999116100054 ()


  • Basic diagnostic x-ray system table, powered
Tibial Jig Body - Triple Pin Vector
Orthalign, Inc.
401648
In Commercial Distribution

  • 00851977007994 ()
401648

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Metal Instrument Tray, 10x10
Orthalign, Inc.
402073
In Commercial Distribution

  • 00851977007987 ()
402073

  • Orthopaedic surgical procedure kit, non-medicated, reusable
Base, Tray, 10x10
Orthalign, Inc.
402073-1
In Commercial Distribution

  • 00851977007970 ()
402073-1

  • Orthopaedic surgical procedure kit, non-medicated, reusable
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