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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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
Prolaryn Plus is a water based injectable gel implant used to treat vocal fold insufficiency. The principle component of Prolaryn Plus is synthetic calcium hydroxyapatite, a biomaterial found in bone and teeth. Injection with Prolaryn Plus augments or bulks ups the displaced or damaged vocal fold so that it can improve speaking. The result is long term restoration and augmentation. Prolaryn Plus can be injected with a 26 gauge or larger diameter thin-wall-needle.
MERZ NORTH AMERICA, INC.
8044M0K5
In Commercial Distribution

  • M2138044M0K55 ()

  • Total Volume: 1.0 Milliliter


  • Injectable vocal cord medialization implant, synthetic
DBX Mix, 20cc
Musculoskeletal Transplant Foundation, Inc.
058200
In Commercial Distribution

  • W4184058200T0474 ()

  • 20 cc volume
058200

  • Bone matrix implant, human-derived
DBX Mix, 10cc
Musculoskeletal Transplant Foundation, Inc.
058100
In Commercial Distribution

  • W4184058100T0474 ()

  • 10 cc volume
058100

  • Bone matrix implant, human-derived
DBX Mix, 5cc
Musculoskeletal Transplant Foundation, Inc.
058050
In Commercial Distribution

  • W4184058050T0474 ()

  • 5 cc volume
058050

  • Bone matrix implant, human-derived
DBX Mix, 2.5cc
Musculoskeletal Transplant Foundation, Inc.
058025
In Commercial Distribution

  • W4184058025T0474 ()

  • 2.5 cc volume
058025

  • Bone matrix implant, human-derived
1.25cc Paste Mix Plus
ISTO TECHNOLOGIES INC
IN012
In Commercial Distribution

  • 00865179000073 ()
IQSP-PP-101

  • Synthetic bone graft
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