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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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9250-ST Telesis® ST Software for Speech Therapy MR Series
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
9250-ST
In Commercial Distribution

  • 00852423006431 ()
9250-ST

  • Biofeedback system application software
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
Uroflowmetry WiFLOW® System
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
WI-LC
In Commercial Distribution

  • 00852423006387 ()
WLC

  • Urine flowmeter, reusable
  • Urodynamic measurement system
Pathway® Musculoskeletal Ultrasound Imaging
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
MSK
In Commercial Distribution

  • 00852423006370 ()
MSK

  • Extracorporeal ultrasound imaging transducer, hand-held
Pathway® Ultrasound Imaging System for Lumbopelvic Rehabilitation
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
TUI
In Commercial Distribution

  • 00852423006363 ()
TUI

  • 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
5-12 MHz 90° Endovaginal Ultrasound Imaging
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
RTTV
In Commercial Distribution

  • 00852423006349 ()
RTTV

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

  • 00852423006332 ()
N/A

  • Extracorporeal ultrasound imaging transducer, hand-held
Quickscan® Bladder Ultrasound Imaging
PROMETHEUS GROUP OF NEW HAMPSHIRE LIMITED, THE
N/A
In Commercial Distribution

  • 00852423006325 ()
QSBU

  • 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
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