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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Airway Sizing Kit
Gyrus Acmi, Llc
HUS-SK
In Commercial Distribution

  • 00896506002125 ()


  • Endobronchial airway sizing kit
No Description
CORTIGENT, INC.
012103-003
Not in Commercial Distribution

012103

  • Retinal prosthesis system tester/clinical evaluator
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
Supplemental Software provided on a thumb drive. Enables programming of the electrical stimulation parameters of the implant.
Second Sight Medical Products, Inc.
014300-000
Not in Commercial Distribution

  • 00856264005776 ()
014300

  • Retinal prosthesis system tester/clinical evaluator
No Description
Second Sight Medical Products, Inc.
014973-000
Not in Commercial Distribution

  • 00856264005523 ()
014973

  • Retinal prosthesis system tester/clinical evaluator
No Description
Second Sight Medical Products, Inc.
014972-000
Not in Commercial Distribution

  • 00856264005516 ()
014972

  • Retinal prosthesis system tester/clinical evaluator
Tool used to rotate the camera on the glasses during during the camera alignment procedure.
Second Sight Medical Products, Inc.
014993-000
Not in Commercial Distribution

  • 00856264005509 ()
014993

  • Retinal prosthesis system tester/clinical evaluator
USB thumb drive containing video settings that can be loaded to the Video Processing Unit.
Second Sight Medical Products, Inc.
014986-001
Not in Commercial Distribution

  • 00856264005493 ()
014986

  • Retinal prosthesis system tester/clinical evaluator
USB thumb drive for transferring selected files from the Clinician Programming System laptop for data analysis.
Second Sight Medical Products, Inc.
014985-001
Not in Commercial Distribution

  • 00856264005486 ()
014985

  • Retinal prosthesis system tester/clinical evaluator
USB thumb drive loaded with security files that contain encrypted login information to enable clinician’s access to the Clinician Programming System laptop.
Second Sight Medical Products, Inc.
014984-001
Not in Commercial Distribution

  • 00856264005479 ()
014984

  • Retinal prosthesis system tester/clinical evaluator
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