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
Prolaryn Gel is a water-based injectable gel implant used in the vocal folds to treat vocal fold insuffiency. Prolaryn Gel resorbs within a period of 3-6 months and is a temporary implant.
MERZ NORTH AMERICA, INC.
8602M0K5
In Commercial Distribution

  • M2138602M0K55 ()

  • Total Volume: 1.0 Milliliter


  • Injectable vocal cord medialization implant, synthetic
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