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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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RD Sedline EEG Sensor Pediatric
MASIMO CORPORATION
4329
In Commercial Distribution

  • 00843997012805 ()
  • 10843997012802 ()
4329

  • Analytical scalp electrode, single-use
Quatro Sensor Kit, (25) 186-0106
Covidien LP
186-0106-PH
In Commercial Distribution

  • 90884521657515 ()
  • 30884521134502 ()


  • Anaesthesia depth monitor
Quatro Sensor Kit, (25) 186-0106
Covidien LP
186-0106-PH
In Commercial Distribution

  • 20884521134505 ()
  • 30884521134502 ()


  • Anaesthesia depth monitor
No Description
Hinacom Software and Technology, Ltd.
V2.0
In Commercial Distribution

  • 06970901070010 ()


  • Radiological PACS software
Hearing implant software
COCHLEAR LIMITED
v7.1, US
In Commercial Distribution

  • 09321502072359 ()
P1947519

  • Audiometric/hearing device software
Hearing implant software
COCHLEAR LIMITED
v 2.0
In Commercial Distribution

  • 09321502070416 ()
P1986795

  • Cochlear implant intraoperative electrophysiological analysis software
Hearing implant software
COCHLEAR LIMITED
P1799437
In Commercial Distribution

  • 09321502065917 ()
P1799437

  • Cochlear implant intraoperative electrophysiological analysis software
3D Echo Software
JOINTVUE, LLC
1.0
Not in Commercial Distribution

  • 00850014885007 ()


  • Ultrasound imaging system operation software
Spine System Software
Fusion Robotics, LLC
5005
In Commercial Distribution

  • 00850026574364 ()


  • Robotic surgical navigation system application software
Clinical Programmer Software
SPR THERAPEUTICS, INC.
50009
In Commercial Distribution

  • 00850022775291 ()
50009

  • Analgesic PENS system
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