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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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IMPLANT ASSEMBLY WITH IPC, SPLIT COIL, RIGHT
Ototronix, LLC
M420R
In Commercial Distribution

  • M737M420R1 ()


  • Partially-implantable middle ear implant system
IMPLANT ASSEMBLY WITH IPC, SPLIT COIL, LEFT
Ototronix, LLC
M420L
In Commercial Distribution

  • M737M420L1 ()


  • Partially-implantable middle ear implant system
IMPLANT ASSEMBLY WITH IPC, RIGHT
Ototronix, LLC
M410R
In Commercial Distribution

  • M737M410R1 ()


  • Partially-implantable middle ear implant system
IMPLANT ASSEMBLY WITH IPC, LEFT
Ototronix, LLC
M410L
In Commercial Distribution

  • M737M410L1 ()


  • Partially-implantable middle ear implant system
MAXUM IPC FIT DEMO
Ototronix, LLC
M3199
In Commercial Distribution

  • M737M31991 ()


  • Partially-implantable middle ear implant system
MAXUM IPC REMAKE
Ototronix, LLC
M3110
In Commercial Distribution

  • M737M31101 ()


  • Partially-implantable middle ear implant system
MAXUM IPC
Ototronix, LLC
M3100
In Commercial Distribution

  • M737M31001 ()


  • Partially-implantable middle ear implant system
IMPLANT ASSEMBLY, SPLIT COIL, RIGHT (IMPLANT ONLY)
Ototronix, LLC
M220R
In Commercial Distribution

  • M737M220R1 ()


  • Partially-implantable middle ear implant system
IMPLANT ASSEMBLY, SPLIT COIL, LEFT (IMPLANT ONLY)
Ototronix, LLC
M220L
In Commercial Distribution

  • M737M220L1 ()


  • Partially-implantable middle ear implant system
IMPLANT ASSEMBLY, RIGHT (IMPLANT ONLY)
Ototronix, LLC
M210R
In Commercial Distribution

  • M737M210R1 ()


  • Partially-implantable middle ear implant system
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