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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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X-Series - 00851113007475

External Syncing Unit - Multi-Channel Kit
ADVANCED BRAIN MONITORING, INC.
ES31-1001, ES31-1003
In Commercial Distribution

  • 00851113007406 ()
  • 00851113007475 ()


  • Medical networking interface unit

X-Series, X8 - 00851113007260

Bluetooth Dongle
ADVANCED BRAIN MONITORING, INC.
31-1003
In Commercial Distribution

  • 00851113007260 ()


  • Medical networking interface unit

Canary Clinic Base Station - 00860003118368

No Description
Canary Medical USA LLC
43-5570-005-14
In Commercial Distribution

  • 00860003118368 ()


  • Medical networking interface unit

Canary Home Base Station - 00860003118320

The CTE with CHIRP Base Station subsystem is a unit with embedded firmware that facilitate communication with the CTE implant to serve as a conduit for implant data transmission in the environments where it will be used. The Home Base Station subsystem is for use by the Patient.
Canary Medical USA LLC
43-5570-001-14
In Commercial Distribution

  • 00860003118320 ()


  • Medical networking interface unit

Ceiba - 00860006137014

Brand-independent integration with Ceiba eConnect APIs of medical devices (monitors, respirators, pumps, blood gas) and hospital systems
Ceiba Healthcare Technologies LLC
ECONNECT IoMT Box
In Commercial Distribution

  • 00860006137014 ()


  • Medical networking interface unit

AURA - 00860011785224

AURA™ Data Receiver Pack
Branchpoint & Aura Development LLC
DG101
In Commercial Distribution

  • 00860011785224 ()
DG101

  • Medical networking interface unit

Lumicell Direct Visualization System (DVS) - 00860003252543

Workstation Assembly
Lumicell, Inc.
810-00217
In Commercial Distribution

  • 00860003252543 ()
  • 00860008537805 ()


  • Intraoperative tumour margin fluorescence imaging system

Lumicell Direct Visualization System (DVS) - 00860003252536

Light source
Lumicell, Inc.
810-00212
In Commercial Distribution

  • 00860003252598 ()
  • 00860003252536 ()


  • Intraoperative tumour margin fluorescence imaging system

Canary OR Base Station / OR PC App / OR Registration - 00860003118313

The OR Base Station subsystem is intended to send and receive data to and from the CTE implant over a wireless communication interface. Data sent to the CTE implant from the OR Base Station activates the CTE implant on the day of surgery.
Canary Medical USA LLC
43-5570-002-14
In Commercial Distribution

  • 00860003118313 ()


  • Medical networking interface unit

IDENTIFY - 00858086006818

No Description
VARIAN MEDICAL SYSTEMS, INC.
4.0
In Commercial Distribution

  • 00858086006818 ()


  • Real-time position management respiratory gating system, optical
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