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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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Sterile Drape
Envoy Medical Corporation
1300
In Commercial Distribution

  • 00812282020528 ()
701300-002

  • Fully-implantable middle ear implant system
Esteem® Commander™ Software Version 3.0
Envoy Medical Corporation
6002
In Commercial Distribution

  • 00812282020504 ()
006002-002

  • Fully-implantable middle ear implant system
Esteem® Commander™ Model 6002
Envoy Medical Corporation
6002
In Commercial Distribution

  • 00812282020498 ()
906002-001

  • Fully-implantable middle ear implant system
Esteem® Commander™ Software Version 2.2
Envoy Medical Corporation
6001
In Commercial Distribution

  • 00812282020481 ()
003873-010

  • Fully-implantable middle ear implant system
Intraoperative System Analyzer (ISA), Sterile Cable, PID to Speaker
Envoy Medical Corporation
3001
In Commercial Distribution

  • 00812282020474 ()
803056-004

  • Fully-implantable middle ear implant system
Intraoperative System Analyzer (ISA), Sterile Cable, PID to Speaker
Envoy Medical Corporation
3001
In Commercial Distribution

  • 00812282020467 ()
803056-003

  • Fully-implantable middle ear implant system
Intraoperative System Analyzer (ISA), Sterile Cable, PID to Microphone
Envoy Medical Corporation
3001
In Commercial Distribution

  • 00812282020450 ()
803056-002

  • Fully-implantable middle ear implant system
Intraoperative System Analyzer (ISA), Sterile Cable, PID to Driver
Envoy Medical Corporation
3001
In Commercial Distribution

  • 00812282020443 ()
803045-002

  • Fully-implantable middle ear implant system
Intraoperative System Analyzer (ISA), Sterile Cable, PID to Sensor
Envoy Medical Corporation
3001
In Commercial Distribution

  • 00812282020436 ()
803050-002

  • Fully-implantable middle ear implant system
Intraoperative System Analyzer (ISA), Software Version 9.0
Envoy Medical Corporation
3001
In Commercial Distribution

  • 00812282020429 ()
004652-005

  • Fully-implantable middle ear implant system
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