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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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CardioMEMS™ - 05414734509206

GSM Antenna
ST. JUDE MEDICAL, INC.
CM1040
In Commercial Distribution

  • 05414734509206 ()
CM1040

  • Implantable pulmonary artery pressure monitoring system

CardioMEMS™ - 05414734509190

Pillow
ST. JUDE MEDICAL, INC.
CM1030
In Commercial Distribution

  • 05414734509190 ()
CM1030

  • Implantable pulmonary artery pressure monitoring system

CardioMEMS™ - 05414734509183

User button
ST. JUDE MEDICAL, INC.
CM1020
In Commercial Distribution

  • 05414734509183 ()
CM1020

  • Implantable pulmonary artery pressure monitoring system

CardioMEMS™ - 05414734509176

No Description
CARDIOMEMS, INC.
CM1010
In Commercial Distribution

  • 05414734509176 ()
CM1010

  • Implantable pulmonary artery pressure monitoring system

CardioMEMS™ - 05414734509169

No Description
CARDIOMEMS, INC.
CM1000
In Commercial Distribution

  • 05414734509169 ()
CM1000

  • Implantable pulmonary artery pressure monitoring 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

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

NeuroPace® Depth Lead Kit - 00855547005342

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

  • 00855547005342 ()

  • 4 electrodes with 3.5 mm spacing
  • Length: 30 Centimeter


  • Brain-responsive electrical stimulation system
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