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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-300M-K
In Commercial Distribution

  • 00855547005120 ()


  • 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

  • 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
Edwards EVOQUE Valve, 56mm
Edwards Lifesciences LLC
9850EV56US
In Commercial Distribution

  • 00690103219074 ()
9850EV56US

  • Tricuspid transcatheter heart valve bioprosthesis
EDWARDS EVOQUE VALVE, 52MM
Edwards Lifesciences LLC
9850EV52US
In Commercial Distribution

  • 00690103217469 ()

  • Outer Diameter: 52 Millimeter
9850EV52US

  • Tricuspid transcatheter heart valve bioprosthesis
EDWARDS EVOQUE VALVE, 48MM
Edwards Lifesciences LLC
9850EV48US
In Commercial Distribution

  • 00690103217452 ()

  • Outer Diameter: 48 Millimeter
9850EV48US

  • Tricuspid transcatheter heart valve bioprosthesis
EDWARDS EVOQUE VALVE, 44MM
Edwards Lifesciences LLC
9850EV44US
In Commercial Distribution

  • 00690103217445 ()

  • Outer Diameter: 44 Millimeter
9850EV44US

  • Tricuspid transcatheter heart valve bioprosthesis
CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS - MITRAL
Edwards Lifesciences LLC
6625-LP
Not in Commercial Distribution

  • 00690103022032 ()

  • MOUNTING DIAMETER (ANNULUS), 35 MILLIMETER
6625LP35

  • Mitral open-surgery heart valve bioprosthesis
CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS - MITRAL
Edwards Lifesciences LLC
6625-LP
Not in Commercial Distribution

  • 00690103022025 ()

  • MOUNTING DIAMETER (ANNULUS), 33 MILLIMETER
6625LP33

  • Mitral open-surgery heart valve bioprosthesis
CARPENTIER-EDWARDS DURAFLEX BIOPROSTHESIS - MITRAL
Edwards Lifesciences LLC
6625-LP
Not in Commercial Distribution

  • 00690103022018 ()

  • MOUNTING DIAMETER (ANNULUS), 31 MILLIMETER
6625LP31

  • Mitral open-surgery heart valve bioprosthesis
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