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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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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
IMPLANT ASSEMBLY, LEFT (IMPLANT ONLY)
Ototronix, LLC
M210L
In Commercial Distribution

  • M737M210L1 ()


  • Partially-implantable middle ear implant system
Impella 5.5 with Smart Assist S2 Set, US
Abiomed, Inc.
1000100
In Commercial Distribution

  • 00813502012828 ()
1000100

  • Intracardiac circulatory assist axial-pump catheter
RP Flex w Smart Assist Set, US
Abiomed, Inc.
1000323
In Commercial Distribution

  • 00813502012811 ()
1000323

  • Intracardiac circulatory assist axial-pump catheter
Pump 381 Pump Set (US)
Abiomed, Inc.
1000080
In Commercial Distribution

  • 00813502012279 ()
0048-0003

  • Intracardiac circulatory assist axial-pump catheter
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