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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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Tack Endovascular System (6F, 3.5-6.0mm) - 00863328000110

80cm Catheter Length
Intact Vascular, Inc.
156080061
In Commercial Distribution

  • 00863328000110 ()

  • Catheter Length: 80 Centimeter
156080061

  • Peripheral artery stent, bare-metal

Tack Endovascular System (6F, 3.5-6.0mm) - 00863328000103

120cm Catheter Length
Intact Vascular, Inc.
156120061
In Commercial Distribution

  • 00863328000103 ()

  • Catheter Length: 120 Centimeter
156120061

  • Peripheral artery stent, bare-metal

NeuroPace® Remote Monitor Kit - 00855547005427

The NeuroPace® Remote Monitor package contains 1 NeuroPace® Remote Monitor, and 1 Carrying Case.
Neuropace, Inc.
5107
In Commercial Distribution

  • 00855547005434 ()
  • 00855547005427 ()


  • Brain-responsive electrical stimulation system

Explant Kit - 00855547005410

The Explant Kit package contains 2 Lead Caps and 1 Torque Driver.
Neuropace, Inc.
EX-01-K
In Commercial Distribution

  • 00855547005410 ()


  • Brain-responsive electrical stimulation system

Remote Monitor Phone Accessories - 00855547005403

The NeuroPace® Remote Monitor Phone Accessories package contains 1 External Modem, 1 Telephone Cord, 1 Telephone Line Splitter.
Neuropace, Inc.
5104
In Commercial Distribution

  • 00855547005403 ()


  • Brain-responsive electrical stimulation system

Connector Cover Kit - 00855547005397

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

  • 00855547005397 ()


  • Brain-responsive electrical stimulation system

Craniectomy Template Kit - 00855547005380

The Craniectomy Template package contains 1 Craniectomy Template, 1 Lead Strain Relief and 1 Torque Driver.
Neuropace, Inc.
CT-01-K
In Commercial Distribution

  • 00855547005380 ()


  • Brain-responsive electrical stimulation system

Ferrule Kit - 00855547005373

The Ferrule package contains 1 Ferrule, 1 Ferrule Clamp and 1 Torque Driver.
Neuropace, Inc.
F-01-K
In Commercial Distribution

  • 00855547005373 ()


  • Brain-responsive electrical stimulation system

RNS® Neurostimulator Kit - 00855547005366

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

  • 00855547005366 ()


  • Brain-responsive electrical stimulation system

NeuroPace® Depth Lead Kit - 00855547005359

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

  • 00855547005359 ()

  • Length: 44 Centimeter
  • 4 electrodes with 3.5 mm spacing


  • Brain-responsive electrical stimulation system
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