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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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Pathway® Rectal Silicon Pressure Sensor
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
6425
In Commercial Distribution

  • 00852423006196 ()
6425

  • Perineometer
Pathway® 6340 Rectal EMG/Stimulation Sensor
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
6340
In Commercial Distribution

  • 00852423006189 ()
6340

  • Perineal orifice incontinence-control electrical stimulation system probe, single-use
  • Perineometer
Pathway® MR-10 Single Channel EMG
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MR-10
In Commercial Distribution

  • 00852423006073 ()
9700

  • Perineometer
  • Psychophysiological biofeedback system
Pathway® MR-15 Single Channel EMG
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MR-15
In Commercial Distribution

  • 00852423006066 ()
9715

  • Perineometer
  • Psychophysiological biofeedback system
Pathway® MR-25 Dual Channel EMG
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MR-25
In Commercial Distribution

  • 00852423006042 ()
9725

  • Perineometer
  • Psychophysiological biofeedback system
Pathway® DUO for Pediatric Voiding Dysfunction
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
PDUO
In Commercial Distribution

  • 00852423006035 ()
PDUO

  • Urine monitoring system monitor
  • Urine monitoring system sensor
  • Urine monitoring system
  • Urine flowmeter, reusable
Pathway® CTS 1500
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
CTS1500
In Commercial Distribution

  • 00852423006028 ()
CTS1500

  • Psychophysiological biofeedback system
  • Perineal orifice incontinence-control electrical stimulation system, professional
Morpheus® Control Module
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MOR0118
In Commercial Distribution

  • 00852423006004 ()
MOR0118

  • Ultrasound imaging system operator console
  • Radiology DICOM image processing application software
  • Urodynamic measurement system
EMYO®100S is a Single Channel EMG System for dysphagia rehabilitation
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
EMYO® 100S
In Commercial Distribution

  • 00852423006486 ()
EM100S

  • Psychophysiological biofeedback system
EMYO®200 is a Dual Channel EMG System for Adult and Pediatric Pelvic Floor Rehabilitation
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
EMYO®200
In Commercial Distribution

  • 00852423006448 ()
EM200

  • Psychophysiological biofeedback system
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