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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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SmartPill - 04260167482897

docking station kit
Given Imaging, Inc.
50100400
In Commercial Distribution

  • 04260167482897 ()


  • Gastrointestinal telemetric monitoring system

SmartPill - 04260167482880

recorder kit
Given Imaging, Inc.
50100500
In Commercial Distribution

  • 04260167482880 ()


  • Gastrointestinal telemetric monitoring system

SmartPill - 04260167482873

MotiliGI notebook kit
Given Imaging, Inc.
30102401
In Commercial Distribution

  • 04260167482873 ()


  • Gastrointestinal telemetric monitoring system

SmartPill - 04260167482712

capsule, single
Given Imaging, Inc.
50100100
In Commercial Distribution

  • 04260167482712 ()


  • Gastrointestinal telemetric monitoring system

SmartPill - 04260167482705

SmartBar, 5-pack
Given Imaging, Inc.
FGS-0505
In Commercial Distribution

  • 04260167482705 ()
  • 10884521726161 ()


  • Gastrointestinal telemetric monitoring system

SmartPill - 04260167482682

capsule, 5-pack
Given Imaging, Inc.
FGS-0503
In Commercial Distribution

  • 04260167482682 ()
  • 10884521726147 ()


  • Gastrointestinal telemetric monitoring system

Smart Check Cushion Monitoring Device - 00613732090289

No Description
Roho, Inc.
SMARTCHK01-DEMO
In Commercial Distribution

  • 00613732090289 ()


  • Wheelchair occupant position sensor

Smart Check Cushion Monitoring Device - 00613732087746

No Description
Roho, Inc.
SMARTCHECK-01
In Commercial Distribution

  • 00613732087746 ()


  • Wheelchair occupant position sensor

NeuroPace® Cortical Strip Lead Kit - 00855547005304

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

NeuroPace® Depth Lead Kit - 00855547005298

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-344-10-K
In Commercial Distribution

  • 00855547005298 ()

  • Length: 44 Centimeter
  • 4 electrodes with 10 mm spacing


  • Brain-responsive electrical stimulation system

RNS® Tablet Kit - 00855547005281

The RNS® Tablet package contains 1 RNS® Tablet, 1 Stylus, 1 AC Adapter and 1 Carrying Case.
Neuropace, Inc.
5001
In Commercial Distribution

  • 00855547005274 ()
  • 00855547005281 ()


  • Brain-responsive electrical stimulation system

RNS® Neurostimulator Kit - 00855547005267

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

NeuroPace® Lead Accessory Kit - 00855547005229

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

Ferrule Kit - 00855547005175

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

Connector Cover Kit - 00855547005151

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

RNS® Neurostimulator Kit - 00855547005120

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

Wand - 00855547005113

The Wand package contains 1 Wand.
Neuropace, Inc.
W-02
In Commercial Distribution

  • 00855547005113 ()
  • 00855547005236 ()


  • Brain-responsive electrical stimulation system

NeuroPace® Programmer Kit - 00855547005106

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

NeuroPace® Remote Monitor Kit - 00855547005090

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

NeuroPace® Remote Monitor Kit - 00855547005083

The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, 1 Carrying Case, 1 Telephone Cord and 1 Telephone Line Splitter.
Neuropace, Inc.
DTR-300-K
In Commercial Distribution

  • 00855547005199 ()
  • 00855547005083 ()


  • Brain-responsive electrical stimulation system
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