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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® 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
Pathway® NMR 200 Dual Channel Module
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
NMR 200
In Commercial Distribution

  • 00852423006394 ()
NMR 200

  • Perineometer
  • Psychophysiological biofeedback system
Pathway® Musculoskeletal Ultrasound Imaging
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MSK
In Commercial Distribution

  • 00852423006370 ()
MSK

  • Extracorporeal ultrasound imaging transducer, hand-held
10-15 MHz 360° Endoanal Ultrasound Imaging
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
RTCU
In Commercial Distribution

  • 00852423006356 ()
RTCU

  • Extracorporeal ultrasound imaging transducer, hand-held
Morpheus® Control Module
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
N/A
Not in Commercial Distribution

  • 00852423006318 ()
N/A

  • Ultrasonic lithotripsy system
  • Ultrasonic lithotripsy system probe, reusable
Adapter for 7400 Disposable Lead Wire Electrodes
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
7100
In Commercial Distribution

  • 00852423006240 ()
7100

  • Kinesiology/electromyographic sensor set
6’ Electrode Lead Wire Set
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
5338
In Commercial Distribution

  • 00852423006226 ()
5338

  • Kinesiology/electromyographic sensor set
Pathway® 6320 Vaginal/Rectal EMG Sensor
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
6320
In Commercial Distribution

  • 00852423006202 ()
6320

  • Perineometer
Pathway® 6330 Vaginal EMG/Stimulation Sensor
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
6330
In Commercial Distribution

  • 00852423006172 ()
6330

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

  • 00852423006165 ()
STM-10

  • Perineal orifice incontinence-control electrical stimulation system, home-use
Pathway® TR-20C Dual Channel EMG Trainer
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
TR-20C
In Commercial Distribution

  • 00852423006158 ()
8625

  • Psychophysiological biofeedback system
Pathway® TR-20 Dual Channel EMG Trainer
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
TR-20
In Commercial Distribution

  • 00852423006141 ()
8620

  • Psychophysiological biofeedback system
Pathway® TR-10C Single Channel EMG Trainer
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
TR-10C
In Commercial Distribution

  • 00852423006134 ()
8615

  • Kinesiology/electromyographic sensor set
Pathway® TR-10 Single Channel EMG Trainer
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
TR-10
In Commercial Distribution

  • 00852423006127 ()
8610

  • Psychophysiological biofeedback system
Pathway® NMR 400 Quad Channel EMG System
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
NMR400
In Commercial Distribution

  • 00852423006110 ()
NMR400

  • Perineometer
Synergy® 3-Dimensional Software for the Pathway® MR Series
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
9225
In Commercial Distribution

  • 00852423006103 ()
9225

  • Biofeedback system application software
Primus® Software for the Pathway® MR Series
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
9275
In Commercial Distribution

  • 00852423006097 ()
9275

  • Biofeedback system application software
Telesis® Software for the Pathway® MR Series
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
9250
In Commercial Distribution

  • 00852423006080 ()
9250

  • Biofeedback system application software
Pathway® MR-20 Dual Channel EMG
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MR-20
In Commercial Distribution

  • 00852423006059 ()
9710

  • Perineometer
  • Psychophysiological biofeedback system
Pathway® CTS 2000
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
CTS2000
In Commercial Distribution

  • 00852423006011 ()
CTS2000

  • Psychophysiological biofeedback system
  • Perineal orifice incontinence-control electrical stimulation system, professional
Convex Array Transducer
Shantou Institute of Ultrasonic Instruments Co., Ltd.
4DL40G
In Commercial Distribution

  • 06938396495022 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
Endocavity Transducer
Shantou Institute of Ultrasonic Instruments Co., Ltd.
V6LN
In Commercial Distribution

  • 06938396493288 ()


  • Rectal/vaginal ultrasound imaging transducer
Linear Array Transducer
Shantou Institute of Ultrasonic Instruments Co., Ltd.
L10LN
In Commercial Distribution

  • 06938396491307 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
Linear Array Transducer
Shantou Institute of Ultrasonic Instruments Co., Ltd.
L7I50
In Commercial Distribution

  • 06938396491147 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
Linear Array Transducer
Shantou Institute of Ultrasonic Instruments Co., Ltd.
L7L38G
In Commercial Distribution

  • 06938396491055 ()


  • Extracorporeal ultrasound imaging transducer, hand-held
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