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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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Small Static Cranial Implant (Primary and Backup)
LONGEVITI NEURO SOLUTIONS LLC
171710
In Commercial Distribution

  • 00855113008005 ()
  • 10855113008002 ()

  • Area/Surface Area: 60 Square centimeter
171710

  • Cranial resinous compound
MedCem Hydroxyapatite Cement
Envoy Medical Corporation
1610
In Commercial Distribution

  • 00812282020603 ()
901610-301

  • 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
EnvoyCem® Glass Ionomer Cement
Envoy Medical Corporation
1640
In Commercial Distribution

  • 00812282020368 ()
901640-002

  • Fully-implantable middle ear implant system
MedCem® Hydroxyapatite Cement
Envoy Medical Corporation
1610
In Commercial Distribution

  • 00812282020283 ()
901610-300

  • Fully-implantable middle ear implant system
MedCem® Hydroxyapatite Cement
Envoy Medical Corporation
1610
In Commercial Distribution

  • 00812282020276 ()
901610-203

  • Fully-implantable middle ear implant system
MedCem® Hydroxyapatite Cement
Envoy Medical Corporation
1610
In Commercial Distribution

  • 00812282020269 ()
901610-202

  • Fully-implantable middle ear implant system
MedCem® Hydroxyapatite Cement
Envoy Medical Corporation
1610
In Commercial Distribution

  • 00812282020252 ()
901610-003

  • Fully-implantable middle ear implant system
Sound Processor Model 2001, IS-1 Connector Ports
Envoy Medical Corporation
2001
In Commercial Distribution

  • 00812282020214 ()
902001-003

  • Fully-implantable middle ear implant system
Sound Processor Model 2001, IS-1 Connector Ports
Envoy Medical Corporation
2001
In Commercial Distribution

  • 00812282020207 ()
902001-002

  • Fully-implantable middle ear implant system
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