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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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HeRO symphony - 00865536000203

Server based HeRO System
MEDICAL PREDICTIVE SCIENCE CORPORATION
3.1
In Commercial Distribution

  • 00865536000203 ()


  • Neonatal/paediatric heart rate monitoring hardware
  • Neonatal/paediatric heart rate monitoring application software

Alpine BioMed - 00721902428531

EP HEADBOX UNIT
Alpine Biomed ApS
8031C0551
Not in Commercial Distribution

  • 00721902428531 ()


  • Electromyograph

Alpine BioMed - 00721902428524

8 CH. AMPLIFIER
Alpine Biomed ApS
8031C0521
Not in Commercial Distribution

  • 00721902428524 ()


  • Electromyograph

Alpine BioMed - 00721902428517

4 CH. AMPLIFIER
Alpine Biomed ApS
8031C0511
Not in Commercial Distribution

  • 00721902428517 ()


  • Electromyograph

Alpine BioMed - 00721902428500

2 CH. AMPLIFIER
Alpine Biomed ApS
8031C0501
Not in Commercial Distribution

  • 00721902428500 ()


  • Electromyograph

SwiftPA Software - 00856264005776

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

Argus ll Clinician Programming System - 00856264005721

Laptop computer that is configured with dedicated, PC-based software that, when connected to the Video Processing Unit, enables programming of the electrical stimulation parameters of the implant.
Second Sight Medical Products, Inc.
014003-006-R
Not in Commercial Distribution

  • 00856264005721 ()
014003

  • Retinal prosthesis system tester/clinical evaluator

Argus ll Glasses Screwdriver - 00856264005523

No Description
Second Sight Medical Products, Inc.
014973-000
Not in Commercial Distribution

  • 00856264005523 ()
014973

  • Retinal prosthesis system tester/clinical evaluator

Argus ll VPU Screwdriver - 00856264005516

No Description
Second Sight Medical Products, Inc.
014972-000
Not in Commercial Distribution

  • 00856264005516 ()
014972

  • Retinal prosthesis system tester/clinical evaluator

Argus ll Camera Rotation Tool - 00856264005509

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
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