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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-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
Injectable Bulking Agent
Carbon Medical Technologies, Inc.
890-216
In Commercial Distribution

  • 00858015005011 ()

  • Total Volume: 3 Milliliter
890-216

  • Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable
Injectable Bulking Agent
Carbon Medical Technologies, Inc.
890-215
In Commercial Distribution

  • 00858015005004 ()

  • Total Volume: 1 Milliliter
890-215

  • Urinary tract reconstructive material, synthetic polymer, non-bioabsorbable
No Description
SYNCARDIA SYSTEMS, LLC
297052-001
In Commercial Distribution

  • 00858000003305 ()


  • Ventricular prosthesis system, pneumatically-powered
No Description
SYNCARDIA SYSTEMS, LLC
395103-001
In Commercial Distribution

  • 00858000003299 ()


  • Ventricular prosthesis system, pneumatically-powered
No Description
SYNCARDIA SYSTEMS, LLC
295600-001
In Commercial Distribution

  • 00858000003282 ()


  • Ventricular prosthesis system, pneumatically-powered
No Description
SYNCARDIA SYSTEMS, LLC
295400-001
In Commercial Distribution

  • 00858000003275 ()


  • Ventricular prosthesis system, pneumatically-powered
No Description
SYNCARDIA SYSTEMS, LLC
295070-001
In Commercial Distribution

  • 00858000003268 ()


  • Ventricular prosthesis system, pneumatically-powered
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