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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Contains one each of MT-201, MT-202, MT-203, MT-204, MT-205, MT-206, MT-207, MT-208, MT-209, MT-210, MT-211, MT-212, & MT-213.
Boston Medical Products, Inc.
MT-200
In Commercial Distribution

  • EBESMT2001 ()
MT-200

  • ENT surgical procedure kit, non-medicated, reusable
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
SilkVoice Injectable Implant, 1cc Syringe, 2 each
SOFREGEN MEDICAL INC.
SV1002
In Commercial Distribution

  • B611SV1002 ()
SV1002

  • Injectable vocal cord medialization implant, synthetic
SilkVoice Injectable Implant, 1cc Syringe, 2 needles
SOFREGEN MEDICAL INC.
SV1001
In Commercial Distribution

  • B611SV10011 ()
SV1001

  • Injectable vocal cord medialization implant, synthetic
SilkVoice Injectable Implant, 1cc Syringe, 2 needles
SOFREGEN MEDICAL INC.
SV1001
In Commercial Distribution

  • B611SV1001 ()
SV1001

  • Injectable vocal cord medialization implant, synthetic
Tray Only
Boston Medical Products, Inc.
MT-225
In Commercial Distribution

  • 14063107102841 ()
MT-225

  • Instrument tray, reusable
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