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 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
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-200P
In Commercial Distribution

  • 14063107102766 ()
MT-200P

  • ENT surgical procedure kit, non-medicated, single-use
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
TRUFILL MIX PACK-LF
MEDLINE INDUSTRIES, INC.
DYNJ0568654B
In Commercial Distribution

  • 10889942074891 ()
DYNJ0568654B

  • General surgical procedure kit, non-medicated, reusable
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
OPIATES PLUS MIX
UTAK LABORATORIES, INC.
OPI+ MIX ET
In Commercial Distribution

  • B800OPIMIXET5 ()
  • B800OPIMIXET0 ()

  • Total Volume: 20 Milliliter
OPI+ MIX ET

  • Multiple drugs of abuse IVD, control
OPIATE QC MIX
UTAK LABORATORIES, INC.
OPIA QC L FCCO
In Commercial Distribution

  • B800OPIAQCLFCCO5 ()
  • B800OPIAQCLFCCO0 ()

  • Total Volume: 25 Milliliter
OPIA QC L FCCO

  • Multiple-therapy therapeutic drug monitoring IVD, control
MIX TIPS (35)
PREMIER DENTAL PRODUCTS COMPANY
3001419
In Commercial Distribution

  • 00348783003734 ()


  • Dental material mixing nozzle
Master Mix Tubes
ABBOTT MOLECULAR INC.
04J71-80
In Commercial Distribution

  • 20884999046485 ()
  • 00884999046481 ()
  • 30884999046482 ()
04J71-80

  • Assay container IVD, single-use
Mix Tips, Luer
Stryker Corporation
2110-0031
Not in Commercial Distribution

  • 30808232000949 ()
  • 00808232000948 ()
2110-0031

  • Orthopaedic cement preparation/delivery kit
SpO2 interface cable/安维生/3.0M/073/客户订做
Unimed Medical Supplies, Inc.
U710-172
In Commercial Distribution

  • 06945664817660 ()


  • Electrical-only medical device connection cable, reusable
MCB SERIES
MAR COR PURIFICATION, INC.
BICARD SYSTEM, MCB212-100, LG 220V/50HZ
In Commercial Distribution

  • 00817492021785 ()

  • 85 x 32 x61
NA

  • Haemodialysis bicarbonate solution preparation mixer
No Description
MAR COR PURIFICATION, INC.
SDS,REMOTE,3 ACID,1 BICARB,100G TANK
In Commercial Distribution

  • 00817492021280 ()

  • Height: 58 Inch
  • Depth: 60 Inch
  • Width: 102 Inch


  • Haemodialysis bicarbonate solution preparation mixer
No Description
MAR COR PURIFICATION, INC.
SDS,REMOTE,2 ACID,1 BICARB,100G TANK
In Commercial Distribution

  • 00817492021273 ()

  • Height: 58 Inch
  • Depth: 60 Inch
  • Width: 102 Inch


  • Haemodialysis bicarbonate solution preparation mixer
No Description
MAR COR PURIFICATION, INC.
SDS,REMOTE,1 ACID,1 BICARB,100G TANK
In Commercial Distribution

  • 00817492021266 ()

  • Height: 58 Inch
  • Depth: 60 Inch
  • Width: 102 Inch


  • Haemodialysis bicarbonate solution preparation mixer
No Description
MAR COR PURIFICATION, INC.
SDS,REMOTE,BICARB ONLY,100G TANK
In Commercial Distribution

  • 00817492021259 ()

  • Height: 58 Inch
  • Depth: 60 Inch
  • Width: 102 Inch


  • Haemodialysis bicarbonate solution preparation mixer
No Description
MAR COR PURIFICATION, INC.
SDS,REMOTE,3 ACID,1 BICARB,70G TANK
In Commercial Distribution

  • 00817492021242 ()

  • Height: 58 Inch
  • Depth: 55 Inch
  • Width: 92 Inch


  • Haemodialysis bicarbonate solution preparation mixer
No Description
MAR COR PURIFICATION, INC.
SDS,REMOTE,2 ACID,1 BICARB,70G TANK
In Commercial Distribution

  • 00817492021235 ()

  • Height: 58 Inch
  • Depth: 55 Inch
  • Width: 92 Inch


  • Haemodialysis bicarbonate solution preparation mixer
No Description
MAR COR PURIFICATION, INC.
SDS,REMOTE,1 ACID,1 BICARB,70G TANK
In Commercial Distribution

  • 00817492021228 ()

  • Height: 58 Inch
  • Depth: 55 Inch
  • Width: 92 Inch


  • Haemodialysis bicarbonate solution preparation mixer
No Description
MAR COR PURIFICATION, INC.
SDS,REMOTE,BICARB ONLY,70G TANK
In Commercial Distribution

  • 00817492021211 ()

  • Height: 58 Inch
  • Depth: 55 Inch
  • Width: 92 Inch


  • Haemodialysis bicarbonate solution preparation mixer
No Description
MAR COR PURIFICATION, INC.
SDS,REMOTE,3 ACID,1 BICARB,HD,100G TANK
In Commercial Distribution

  • 00817492021204 ()

  • Height: 58 Inch
  • Depth: 60 Inch
  • Width: 102 Inch


  • Haemodialysis bicarbonate solution preparation mixer
No Description
MAR COR PURIFICATION, INC.
SDS,REMOTE,2 ACID,1 BICARB,HD,100G TANK
In Commercial Distribution

  • 00817492021198 ()

  • Height: 58 Inch
  • Depth: 60 Inch
  • Width: 102 Inch


  • Haemodialysis bicarbonate solution preparation mixer
No Description
MAR COR PURIFICATION, INC.
SDS,REMOTE,1 ACID,1 BICARB,HD,100G TANK
In Commercial Distribution

  • 00817492021181 ()

  • Height: 58 Inch
  • Depth: 60 Inch
  • Width: 102 Inch


  • Haemodialysis bicarbonate solution preparation mixer
No Description
MAR COR PURIFICATION, INC.
SDS,REMOTE,BICARB ONLY,HD,100G,TANK
In Commercial Distribution

  • 00817492021174 ()

  • Height: 58 Inch
  • Depth: 60 Inch
  • Width: 102 Inch


  • Haemodialysis bicarbonate solution preparation mixer
No Description
MAR COR PURIFICATION, INC.
SDS,REMOTE,3 ACID,1 BICARB,HD,70G TANK
In Commercial Distribution

  • 00817492021167 ()

  • Height: 58 Inch
  • Depth: 55 Inch
  • Width: 92 Inch


  • Haemodialysis bicarbonate solution preparation mixer
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