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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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Accessory device that mounts to the source side of a 9 inch C-Arm
TrackX Technology, LLC
9 inch Source Cap Original Assembly
In Commercial Distribution

  • 00857088008028 ()
TX-3-3091

  • Diagnostic x-ray digital imaging system workstation application software
Accessory device that mounts to the detector side of a 9 inch C-Arm
TrackX Technology, LLC
9 inch C-Arm Collar Assembly
Not in Commercial Distribution

  • 00857088008011 ()
TX-3-3086

  • Diagnostic x-ray digital imaging system workstation application software
Accessory device that mounts to the detector side of a 12 inch C-Arm
TrackX Technology, LLC
12 inch C-Arm Collar Assembly
Not in Commercial Distribution

  • 00857088008004 ()
TX-3-3142

  • Diagnostic x-ray digital imaging system workstation application software
The ReWalk 7 Personal Exoskeleton is a wearable, battery-powered prescription device intended for use by certified individuals at least 18 years old with lower limb disability to perform routine ambulatory functions at home and in the community. Control of the exoskeleton is achieved through a user-worn wireless, web connected wrist control unit (WCU), a wireless crutch-mounted control unit (CCU), and specific body movements as measured through a tilt sensor. The powered device movements are performed by a set of gears and motors at the knee and the hip joints. The ReWalk 7 Personal Exoskeleton includes the exoskeleton (incl. rigid frames, waist pack, and straps), battery power supply, crutches with integrated powered crutch control add-on unit (CCU), and the Wrist Control Unit (WCU). The wireless, web connected therapist handheld device (THD) is used by certified therapists for device configuration and control. All ReWalk 7 Personal Exoskeleton components are suitable for indoor and outdoor use. The ReWalk use includes standing, walking on level surfaces, mild slopes, ascending and descending stairs and curbs.
LIFEWARD LTD
ReWalk 7
In Commercial Distribution

  • 00860001744514 ()
50-20-0005

  • Programmable ambulation exoskeleton, home-use
Aluna Spirometer
KNOX MEDICAL DIAGNOSTICS INC.
000050-FGI
In Commercial Distribution

  • 00860000654005 ()


  • Expiratory peak flow meter, digital
Gentuity OCT imaging console, including optical engine, PC, PIM with umbilical, 2 monitors (one with touch screen) and keyboard/mouse.
GENTUITY LLC
Gentuity Imaging System G10-01 K192922
In Commercial Distribution

  • 00859910007032 ()


  • Coronary optical coherence tomography system
Medical device accessories intended for ABR measurements
Interacoustics A/S
TM electrode for ECochG, starter kit
In Commercial Distribution

  • 05711117229783 ()
8013209

  • Evoked-potential audiometer
Medical device accessories intended for ABR measurements
Interacoustics A/S
EARturtle, slide w/ wipes and Tab electrodes
In Commercial Distribution

  • 05711117227628 ()
  • 05711117230116 ()
8533504

  • Evoked-potential audiometer
Medical device accessories intended for ABR measurements
Interacoustics A/S
EARturtle, slide w/ wipes and Snap electrodes
In Commercial Distribution

  • 05711117227611 ()
  • 05711117230123 ()


  • Evoked-potential audiometer
Accessory for Real Ear Measurement (REM), blue
Interacoustics A/S
Sanibel REM Probe Tubes, type C
In Commercial Distribution

  • 05711117228564 ()
  • 05711117227574 ()
  • 05711117228526 ()
8533303 (50 pcs)

  • Audiometric/hearing aid tester
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