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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LEAD 4351-35 ENTERRA GASTRIC EMAN FWU
MEDTRONIC, INC.
4351-35
In Commercial Distribution

  • 00643169887589 ()


  • Gastric electrical stimulation system
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
Used during the camera alignment procedure or other tests to record the patient’s responses.
Second Sight Medical Products, Inc.
014932-001
Not in Commercial Distribution

  • 00856264005462 ()
014932

  • Retinal prosthesis system tester/clinical evaluator
Laptop computer that is connected to the Clinician Programming System. It can be used to run performance evaluation software.
Second Sight Medical Products, Inc.
014202-002-R
Not in Commercial Distribution

  • 00856264005417 ()
014202

  • 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.
Second Sight Medical Products, Inc.
014103-002
Not in Commercial Distribution

  • 00856264005400 ()
014103

  • Retinal prosthesis system tester/clinical evaluator
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