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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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CASE MEDICAL - 00653159007392

CONTAINER SOLERA™ 5.5/6.0 DRIVER
Case Medical Inc.
9735218
In Commercial Distribution

  • 00653159007392 ()
9735218

  • Device sterilization/disinfection container, reusable

CASE MEDICAL - 00653159007279

CONTAINER SOLERA™ TAPS DRIVERS
Case Medical Inc.
9734444
In Commercial Distribution

  • 00653159007279 ()
9734444

  • Device sterilization/disinfection container, reusable

CASE MEDICAL - 00653159007262

CONTAINER LEGACY™ TAPS DRIVERS
Case Medical Inc.
9734443
In Commercial Distribution

  • 00653159007262 ()
9734443

  • Device sterilization/disinfection container, reusable

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

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

RNS® Neurostimulator Kit - 00855547005267

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

  • 00855547005267 ()


  • Brain-responsive electrical stimulation system

Burr Hole Cover - 00855547005205

The Burr Hole Cover package contains 1 Burr Hole Cover.
Neuropace, Inc.
8110
In Commercial Distribution

  • 00855547005205 ()

  • Compatible with a 1.3 mm lead. Requires three 1.5 to 1.8 mm bone screws.
  • Outer Diameter: 14 Millimeter


  • Cranial bur hole cover
  • Craniofacial fixation plate, non-bioabsorbable, non-customized
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