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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Size: Male 8
Boston Medical Products, Inc.
MTM-08
In Commercial Distribution

  • EBESMTM080 ()
  • EBESMTM081 ()

  • Size: Male 8
MTM-08

  • Preformed vocal cord medialization implant
Size: Female 11
Boston Medical Products, Inc.
MTF-11
In Commercial Distribution

  • EBESMTF110 ()
  • EBESMTF111 ()

  • Size: Female 11
MTF-11

  • Preformed vocal cord medialization implant
Size: Female 8
Boston Medical Products, Inc.
MTF-08
In Commercial Distribution

  • EBESMTF080 ()
  • EBESMTF081 ()

  • Size: Female 8
MTF-08

  • Preformed vocal cord medialization implant
Size: Female 6
Boston Medical Products, Inc.
MTF-06
In Commercial Distribution

  • EBESMTF060 ()
  • EBESMTF061 ()

  • Size: Female 6
MTF-06

  • Preformed vocal cord medialization implant
Type: Female. Contains two each of MTF-06 & MTF-07. Contains four each of MTF-08, MTF-09, & MTF-10.
Boston Medical Products, Inc.
MTF-01
In Commercial Distribution

  • EBESMTF011 ()
MTF-01

  • Preformed vocal cord medialization implant
SilkVoice injectable implant and accessory kit.
SOFREGEN MEDICAL INC.
SV3001
In Commercial Distribution

  • B611SV30012 ()
SV3001

  • Injectable vocal cord medialization implant, synthetic
SilkVoice injectable implant and accessory kit.
SOFREGEN MEDICAL INC.
SV3001
In Commercial Distribution

  • B611SV3001 ()
SV3001

  • Injectable vocal cord medialization implant, synthetic
SilkVoice catheter 70cm
SOFREGEN MEDICAL INC.
SV2001
In Commercial Distribution

  • B611SV20011 ()
SV2001

  • Injectable vocal cord medialization implant, synthetic
SilkVoice catheter 70cm
SOFREGEN MEDICAL INC.
SV2001
In Commercial Distribution

  • B611SV2001 ()
SV2001

  • Injectable vocal cord medialization implant, synthetic
SilkVoice Injectable Implant, 1cc Syringe, 2 each
SOFREGEN MEDICAL INC.
SV1002
In Commercial Distribution

  • B611SV10021 ()
SV1002

  • Injectable vocal cord medialization implant, synthetic
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