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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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BSD-2000 Hyperthermia System - 00864445000441

The BSD-2000 system is a prescription device that is intended to deliver hyperthermia, which has been shown to increase the sensitivity of tumor cells to radiation or chemotherapy by the external application of electromagnetic energy. The system provides hyperthermia to solid tumors by generating and applying radio frequency (RF) energy.
Pyrexar Medical Inc.
BSD-2000U
In Commercial Distribution



  • Microwave hyperthermia system

BSD-2000 Hyperthermia System - 00864445000403

The BSD-2000 system is a prescription device that is intended to deliver hyperthermia, which has been shown to increase the sensitivity of tumor cells to radiation or chemotherapy by the external application of electromagnetic energy. The system provides hyperthermia to solid tumors by generating and applying radio frequency (RF) energy.
Pyrexar Medical Inc.
BSD-2000B
In Commercial Distribution



  • Microwave hyperthermia system

Argus II Operating Room Coil - 00850052743161

No Description
CORTIGENT, INC.
012103-003
Not in Commercial Distribution

012103

  • Retinal prosthesis system tester/clinical evaluator

Argus II Glasses, Left Eye, Clear Lenses - 00850052743130

The Argus II Glasses provide a convenient and discreet way to house the video camera for capturing images and the radio-frequency system needed to power and communicate with the implant. A small, light-weight color video camera is mounted in the center of the glasses frame above the nose-piece. A telemetry coil and radio-frequency system are mounted on the arm of the glasses frame.
CORTIGENT, INC.
012014-003
Not in Commercial Distribution

012014

  • Video-camera epiretinal prosthesis system camera spectacles

Argus II Glasses, Left Eye, Dark Lenses - 00850052743123

The Argus II Glasses provide a convenient and discreet way to house the video camera for capturing images and the radio-frequency system needed to power and communicate with the implant. A small, light-weight color video camera is mounted in the center of the glasses frame above the nose-piece. A telemetry coil and radio-frequency system are mounted on the arm of the glasses frame.
CORTIGENT, INC.
012013-003
Not in Commercial Distribution

012013

  • Video-camera epiretinal prosthesis system camera spectacles

Argus II Glasses, Right Eye, Clear Lenses - 00850052743116

The Argus II Glasses provide a convenient and discreet way to house the video camera for capturing images and the radio-frequency system needed to power and communicate with the implant. A small, light-weight color video camera is mounted in the center of the glasses frame above the nose-piece. A telemetry coil and radio-frequency system are mounted on the arm of the glasses frame.
CORTIGENT, INC.
012012-003
Not in Commercial Distribution

012012

  • Video-camera epiretinal prosthesis system camera spectacles

Argus II Glasses - Right Eye - Dark Lenses - 00850052743109

The Argus II Glasses provide a convenient and discreet way to house the video camera for capturing images and the radio-frequency system needed to power and communicate with the implant. A small, light-weight color video camera is mounted in the center of the glasses frame above the nose-piece. A telemetry coil and radio-frequency system are mounted on the arm of the glasses frame.
CORTIGENT, INC.
012011-003
Not in Commercial Distribution

012011

  • Video-camera epiretinal prosthesis system camera spectacles

Argus II Communication Adapter (CA) - 00850052743055

A device which provides data communication and electrical isolation between the Video Processing Unit and the Clinician Programming System.
CORTIGENT, INC.
014103-002
Not in Commercial Distribution

014103

  • Retinal prosthesis system tester/clinical evaluator

Argus II Video Processing Unit (VPU) - 00850052743000

The VPU is used to process the images from the video camera (on the Glasses) and convert the images into electrical stimulation commands which are transmitted wirelessly to the implant. The VPU is worn by the patient, typically on a belt or a strap.
CORTIGENT, INC.
013003-006
Not in Commercial Distribution

013003

  • Video-camera epiretinal prosthesis system visual processing unit

BSD-2000 Hyperthermia System - 08644450004106

The BSD-2000 system is a prescription device that is intended to deliver hyperthermia, which has been shown to increase the sensitivity of tumor cells to radiation or chemotherapy by the external application of electromagnetic energy. The system provides hyperthermia to solid tumors by generating and applying radio frequency (RF) energy.
Pyrexar Medical Inc.
BSD-2000U
Not in Commercial Distribution



  • Microwave hyperthermia system
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