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 Type Device Class Implantable

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Surgical Replica of Model 7510 Driver
Envoy Medical Corporation
1510
In Commercial Distribution

  • 00812282020405 ()

  • Surgical Replica of Model 7510 Driver
005774-001

  • Fully-implantable middle ear implant system
Driver Replica
Envoy Medical Corporation
1510
In Commercial Distribution

  • 00812282020382 ()

  • Surgical Replica of Model 7504 Driver
  • Surgical Replica of Model 7502 Driver
002971-001

  • Fully-implantable middle ear implant system
Transducer Replicas
Envoy Medical Corporation
1510
In Commercial Distribution

  • 00812282020306 ()

  • Surgical Replica of Model 7010 Sensor
  • Surgical Replica of Model 7510 Driver
901510-002

  • Fully-implantable middle ear implant system
Transducer Replicas
Envoy Medical Corporation
1510
In Commercial Distribution

  • 00812282020290 ()

  • Surgical Replica of Model 7004 Sensor
  • Surgical Replica of Model 7002 Sensor
  • Surgical Replica of Model 7504 Driver
  • Surgical Replica of Model 7502 Driver
901510-001

  • Fully-implantable middle ear implant system
Driver Model 7510, IS-1 Connector
Envoy Medical Corporation
7510
In Commercial Distribution

  • 00812282020030 ()
907510-001

  • Fully-implantable middle ear implant system
Driver Model 7504, IS-1 Connector
Envoy Medical Corporation
7504
In Commercial Distribution

  • 00812282020023 ()
907504-003

  • Fully-implantable middle ear implant system
Driver Model 7504, IS-1 Connector
Envoy Medical Corporation
7504
In Commercial Distribution

  • 00812282020016 ()
907504-001

  • Fully-implantable middle ear implant system
No Description
Abiomed, Inc.
AB Portable Driver, Packaged
Not in Commercial Distribution

  • 00813502010114 ()


  • Intracardiac circulatory assist axial-pump catheter
No Description
Thoratec Corporation
100621
In Commercial Distribution

  • 00813024013396 ()
100621

  • Implantable ventricular circulatory assist system control unit
No Description
Thoratec Corporation
10025-2600-005
In Commercial Distribution

  • 00813024013303 ()
10025-2600-005

  • Implantable ventricular circulatory assist system control unit
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