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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® 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

  • 00855547005038 ()

  • 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-344-3.5-K
In Commercial Distribution

  • 00855547005021 ()

  • 4 electrodes with 3.5 mm spacing
  • Length: 44 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-344-10-K
In Commercial Distribution

  • 00855547005014 ()

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


  • Brain-responsive electrical stimulation system
The NeuroPace® Patient Data Management System (PDMS), part of the NeuroPace® RNS® System, is used to store and provide access to historical RNS® Neurostimulator and patient data. The PDMS can also be used to create and simulate detection settings that can be sent to a user identified NeuroPace® Programmer for use at a later date. PDMS is stand-alone software that is accessible via secure internet connection.
Neuropace, Inc.
Model 4340
In Commercial Distribution

  • 00855547005007 ()


  • Cannulated surgical drill bit, reusable
LINX Reflux Management System
Torax Medical, Inc.
LXMC17
In Commercial Distribution

  • 00855106005370 ()
LXMC17

  • Gastro-oesophageal antireflux prosthesis
LINX Reflux Management System
Torax Medical, Inc.
LXMC16
In Commercial Distribution

  • 00855106005363 ()
LXMC16

  • Gastro-oesophageal antireflux prosthesis
LINX Reflux Management System
Torax Medical, Inc.
LXMC15
In Commercial Distribution

  • 00855106005356 ()
LXMC15

  • Gastro-oesophageal antireflux prosthesis
LINX Reflux Management System
Torax Medical, Inc.
LXMC14
In Commercial Distribution

  • 00855106005349 ()
LXMC14

  • Gastro-oesophageal antireflux prosthesis
LINX Reflux Management System
Torax Medical, Inc.
LXMC13
In Commercial Distribution

  • 00855106005332 ()
LXMC13

  • Gastro-oesophageal antireflux prosthesis
No Description
Torax Medical, Inc.
LXMC12
In Commercial Distribution

  • 00855106005325 ()


  • Gastro-oesophageal antireflux prosthesis
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