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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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.
Second Sight Medical Products, Inc.
012013-003
Not in Commercial Distribution

  • 00856264005370 ()
012013

  • Video-camera epiretinal prosthesis system camera spectacles
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.
Second Sight Medical Products, Inc.
012014-003
Not in Commercial Distribution

  • 00856264005363 ()
012014

  • Video-camera epiretinal prosthesis system camera spectacles
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.
Second Sight Medical Products, Inc.
012011-003
Not in Commercial Distribution

  • 00856264005356 ()
012011

  • Video-camera epiretinal prosthesis system camera spectacles
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.
Second Sight Medical Products, Inc.
012012-003
Not in Commercial Distribution

  • 00856264005349 ()
012012

  • Video-camera epiretinal prosthesis system camera spectacles
Elana Surical Kit HUD The Elana Sutrgical Kit HUD contains: The Elana Laser Catheter 2.0, The Elana Rings 2.6&2.8 and a vacuum extension tube. The Elana Surgical Kit HUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large [> 2.5 mm], intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity.
Elana B.V.
1
In Commercial Distribution

  • M602801H00013 ()
801-H.00.01

  • Vascular-grafting anastomosis system
The operating room coil is used during surgery in replacement of the glasses. A telemetry coil and radio-frequency system are mounted on the device to provide communication between the implant and the VPU during surgery.
Second Sight Medical Products, Inc.
012103-003
Not in Commercial Distribution

  • 00856264005387 ()
012103

  • Retinal prosthesis system implantation test coil
FENIX Beaded Sizer
Torax Medical, Inc.
FXBS
Not in Commercial Distribution

  • 00855106005547 ()


  • Anal sphincter prosthesis
No Description
Torax Medical, Inc.
FXS-[20]
Not in Commercial Distribution

  • 00855106005530 ()


  • Anal sphincter prosthesis
No Description
Torax Medical, Inc.
FXS-[19]
Not in Commercial Distribution

  • 00855106005523 ()


  • Anal sphincter prosthesis
No Description
Torax Medical, Inc.
FXS-[18]
Not in Commercial Distribution

  • 00855106005516 ()


  • Anal sphincter prosthesis
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