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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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HEAD RING SCREWS LONG - 07290015461368

Single use screws connecting stereotactic frame with patient skull during neuro MRI guided FUS treatment.
INSIGHTEC LTD
MPR000444-AA HEAD RING SCREWS LONG SET
In Commercial Distribution

  • 07290015461368 ()
MPR000444-AA

  • Therapeutic oncological/gynaecological ultrasound system

alpHaONE - 06946332804173

pH capsule
Chongqing Jinshan Science & Technology (Group) Co., Ltd
JSPC-1
In Commercial Distribution

  • 16946332804170 ()
  • 06946332804173 ()


  • Gastrointestinal telemetric monitoring system capsule, ingestible

alpHaONE - 06946332800045

pH capsule, 1 pack
Chongqing Jinshan Science & Technology (Group) Co., Ltd
JSPC-1
In Commercial Distribution

  • 06946332800625 ()
  • 06946332800045 ()
  • 06946332800632 ()


  • Gastrointestinal telemetric monitoring system capsule, ingestible

Inspire - 00855728005796

The Inspire® Stimulation Lead (Model 4063) is designed to deliver stimulation to the hypoglossal nerve for the treatment of obstructive sleep apnea. The lead features a flexible, self-sizing cuff. Electrodes in the inner surface of the cuff deliver stimulation to the nerve. The lead incorporates a standard connector for coupling to the Inspire implantable pulse generator (IPG).
Inspire Medical Systems, Inc.
900-013-001
Not in Commercial Distribution

  • 00855728005796 ()
4340

  • Implantable sleep apnoea treatment system, respiration-sensing

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

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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