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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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The Inspire® Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG).
Inspire Medical Systems, Inc.
900-013-001
In Commercial Distribution

  • 00855728005796 ()
4340

  • Implantable sleep apnoea treatment system, respiration-sensing
The Model 2740 physician programmer is designed for use by a physician to non invasively interrogate and program the IPG. It is the only component in the Inspire system that contains software. This programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates with the IPG through the skin via short range radio frequency (RF) telemetry, telemetry communication allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician programmer tablet. The physician programmer has the capability to monitor respiratory waveforms, program stimulation modes, adjust stimulation parameter values, and store waveforms and settings.
Inspire Medical Systems, Inc.
900-004-111
In Commercial Distribution

  • 00855728005741 ()
2740

  • Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, and 1 Carrying Case.
Neuropace, Inc.
5107
In Commercial Distribution

  • 00855547005434 ()
  • 00855547005427 ()


  • Brain-responsive electrical stimulation system
The NeuroPace® Remote Monitor Phone Accessories package contains 1 External Modem, 1 Telephone Cord, 1 Telephone Line Splitter.
Neuropace, Inc.
5104
In Commercial Distribution

  • 00855547005403 ()


  • Brain-responsive electrical stimulation system
The NeuroPace® Depth Lead package contains 1 Depth Lead, 2 Lead Caps, 4 Suture Sleeves, 1 Stop Gauge and 1 Tunneling Tool Straw.
Neuropace, Inc.
DL-344-3.5-K
In Commercial Distribution

  • 00855547005359 ()

  • Length: 44 Centimeter
  • 4 electrodes with 3.5 mm spacing


  • Brain-responsive electrical stimulation system
The NeuroPace® Depth Lead package contains 1 Depth Lead, 2 Lead Caps, 4 Suture Sleeves, 1 Stop Gauge and 1 Tunneling Tool Straw.
Neuropace, Inc.
DL-330-3.5-K
In Commercial Distribution

  • 00855547005342 ()

  • 4 electrodes with 3.5 mm spacing
  • Length: 30 Centimeter


  • Brain-responsive electrical stimulation system
The NeuroPace® Depth Lead package contains 1 Depth Lead, 2 Lead Caps, 4 Suture Sleeves, 1 Stop Gauge and 1 Tunneling Tool Straw.
Neuropace, Inc.
DL-330-10-K
In Commercial Distribution

  • 00855547005335 ()

  • 4 electrodes with 10 mm spacing
  • Length: 30 Centimeter


  • Brain-responsive electrical stimulation system
The NeuroPace® Cortical Strip Lead package contains 1 Cortical Strip Lead, 2 Lead Caps, 4 Suture Sleeves and 1 Tunneling Tool Straw.
Neuropace, Inc.
CL-315-10-K
In Commercial Distribution

  • 00855547005328 ()

  • Length: 15 Centimeter
  • 4 electrodes with 10 mm spacing


  • Brain-responsive electrical stimulation system
The NeuroPace® Cortical Strip Lead package contains 1 Cortical Strip Lead, 2 Lead Caps, 4 Suture Sleeves and 1 Tunneling Tool Straw.
Neuropace, Inc.
CL-325-10-K
In Commercial Distribution

  • 00855547005311 ()

  • 4 electrodes with 10 mm spacing
  • Length: 25 Centimeter


  • Brain-responsive electrical stimulation system
The NeuroPace® Cortical Strip Lead package contains 1 Cortical Strip Lead, 2 Lead Caps, 4 Suture Sleeves and 1 Tunneling Tool Straw.
Neuropace, Inc.
CL-335-10-K
In Commercial Distribution

  • 00855547005304 ()

  • Length: 35 Centimeter
  • 4 electrodes with 10 mm spacing


  • Brain-responsive electrical stimulation system
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