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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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Esteem® MedCem® - 00812282020269

MedCem® Hydroxyapatite Cement
Envoy Medical Corporation
1610
In Commercial Distribution

  • 00812282020269 ()
901610-202

  • Fully-implantable middle ear implant system

Esteem® MedCem® - 00812282020252

MedCem® Hydroxyapatite Cement
Envoy Medical Corporation
1610
In Commercial Distribution

  • 00812282020252 ()
901610-003

  • Fully-implantable middle ear implant system

Esteem® Sound Processor - 00812282020214

Sound Processor Model 2001, IS-1 Connector Ports
Envoy Medical Corporation
2001
In Commercial Distribution

  • 00812282020214 ()
902001-003

  • Fully-implantable middle ear implant system

Esteem® Sound Processor - 00812282020207

Sound Processor Model 2001, IS-1 Connector Ports
Envoy Medical Corporation
2001
In Commercial Distribution

  • 00812282020207 ()
902001-002

  • Fully-implantable middle ear implant system

Esteem® Commander™ - 00812282020122

Esteem® Commander™ Model 6001
Envoy Medical Corporation
6001
In Commercial Distribution

  • 00812282020122 ()
906011-102

  • Fully-implantable middle ear implant system

Esteem® Personal Programmer - 00812282020078

Personal Programmer Model 8001
Envoy Medical Corporation
8001
In Commercial Distribution

  • 00812282020078 ()
908001-101

  • Fully-implantable middle ear implant system

Esteem® Sensor - 00812282020054

Sensor Model 7004, IS-1 Connector
Envoy Medical Corporation
7004
In Commercial Distribution

  • 00812282020054 ()
907004-003

  • Fully-implantable middle ear implant system

Esteem® Sensor - 00812282020047

Sensor Model 7004, IS-1 Connector
Envoy Medical Corporation
7004
In Commercial Distribution

  • 00812282020047 ()
907004-001

  • Fully-implantable middle ear implant system

Esteem® Driver - 00812282020030

Driver Model 7510, IS-1 Connector
Envoy Medical Corporation
7510
In Commercial Distribution

  • 00812282020030 ()
907510-001

  • Fully-implantable middle ear implant system

Esteem® Driver - 00812282020023

Driver Model 7504, IS-1 Connector
Envoy Medical Corporation
7504
In Commercial Distribution

  • 00812282020023 ()
907504-003

  • Fully-implantable middle ear implant system
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