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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® 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

Esteem® Driver - 00812282020016

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

  • 00812282020016 ()
907504-001

  • Fully-implantable middle ear implant system

Esteem® Sensor - 00812282020009

Sensor Model 7010, IS-1 Connector
Envoy Medical Corporation
7010
In Commercial Distribution

  • 00812282020009 ()
907010-001

  • Fully-implantable middle ear implant system

Esteem® Commander™ - 00812282020498

Esteem® Commander™ Model 6002
Envoy Medical Corporation
6002
In Commercial Distribution

  • 00812282020498 ()
906002-001

  • Fully-implantable middle ear implant system

Esteem® MedCem® - 00812282020276

MedCem® Hydroxyapatite Cement
Envoy Medical Corporation
1610
In Commercial Distribution

  • 00812282020276 ()
901610-203

  • 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 - 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

ToggleLoc With Ziploop - 00880304453364

No Description
Biomet Orthopedics, LLC
904755
In Commercial Distribution

  • 00880304453364 ()
904755

  • Tendon/ligament bone anchor, non-bioabsorbable

ToggleLoc With Ziploop - 00880304464858

No Description
Biomet Orthopedics, LLC
904754
In Commercial Distribution

  • 00880304464858 ()
904754

  • Tendon/ligament bone anchor, non-bioabsorbable
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