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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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
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
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
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
Pin Driver; Gen II
Stryker GmbH
901-0125
In Commercial Distribution

  • 00886385027081 ()
901-0125

  • Surgical implant template, reusable
CMC, Metacarpal Impactor
Stryker GmbH
17-0314
In Commercial Distribution

  • 00886385025698 ()


  • Orthopaedic implant driver
PIN PULLER
Stryker GmbH
933-0024
In Commercial Distribution

  • 00886385019024 ()


  • Surgical screwdriver, reusable
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