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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 NeuroPace® RNS® Neurostimulator package contains 1 RNS® Neurostimulator, 1 Connector Cover, 1 Ferrule, 1 Ferrule Clamp, 1 Lead Strain Relief and 1 Torque Driver.
Neuropace, Inc.
RNS-320-K
In Commercial Distribution

  • 00855547005267 ()


  • Brain-responsive electrical stimulation system
The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, 1 Carrying Case, and 1 Ethernet (Network) Cable.
Neuropace, Inc.
5101
In Commercial Distribution

  • 00855547005243 ()
  • 00855547005250 ()


  • Brain-responsive electrical stimulation system
The NeuroPace® Lead Accessory package contains 2 Lead Caps, 4 Suture Sleeves, 1 Stop Gauge, 1 Tunneling Tool, 1 Tunneling Tool Tip and 1 Tunneling Tool Straw.
Neuropace, Inc.
LA-02-K
In Commercial Distribution

  • 00855547005229 ()


  • Brain-responsive electrical stimulation system
The Ferrule package contains 1 Ferrule, 1 Ferrule Clamp and 1 Torque Driver.
Neuropace, Inc.
F-01-K
In Commercial Distribution

  • 00855547005175 ()


  • Brain-responsive electrical stimulation system
The Craniectomy Template package contains 1 Craniectomy Template, 1 Lead Strain Relief and 1 Torque Driver.
Neuropace, Inc.
CT-01-K
In Commercial Distribution

  • 00855547005168 ()


  • Brain-responsive electrical stimulation system
The Connector Cover package contains 1 Connector Cover, 2 Connector Plugs, 1 Lead Strain Relief and 1 Torque Driver.
Neuropace, Inc.
CC-01-K
In Commercial Distribution

  • 00855547005151 ()


  • Brain-responsive electrical stimulation system
The NeuroPace® RNS® Neurostimulator package contains 1 RNS® Neurostimulator, 1 Connector Cover, 1 Ferrule, 1 Ferrule Clamp, 1 Lead Strain Relief and 1 Torque Driver.
Neuropace, Inc.
RNS-300M-K
In Commercial Distribution

  • 00855547005120 ()


  • Brain-responsive electrical stimulation system
The Wand package contains 1 Wand.
Neuropace, Inc.
W-02
In Commercial Distribution

  • 00855547005113 ()
  • 00855547005236 ()


  • Brain-responsive electrical stimulation system
The NeuroPace® Programmer package contains 1 NeuroPace® Programmer and 1 Carrying Case.
Neuropace, Inc.
PGM-300-K
In Commercial Distribution

  • 00855547005212 ()
  • 00855547005106 ()


  • Brain-responsive electrical stimulation system
The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, 1 Carrying Case and 1 Ethernet (Network) Cable.
Neuropace, Inc.
DTR-300-E-K
In Commercial Distribution

  • 00855547005182 ()
  • 00855547005090 ()


  • Brain-responsive electrical stimulation system
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