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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Renú Calcium Hydroxylapatite Vocal Fold Implant is a sterile, semi-solid, cohesive implant indicated for vocal fold medialization and vocal fold insufficiency that may be improved by injection of a soft tissue-bulking agent.
CYTOPHIL, INC.
08-015-04-V04
In Commercial Distribution

  • 00856509002294 ()

  • Total Volume: 1.5 Milliliter
08-015-04-V04

  • Injectable vocal cord medialization implant, synthetic
No Description
LAMBSMEAD LTD
8071M5K1
In Commercial Distribution

  • 05060457760082 ()


  • Dermal tissue reconstructive material, animal-derived
Size: Male 13
Boston Medical Products, Inc.
MTM-13
In Commercial Distribution

  • EBESMTM130 ()
  • EBESMTM131 ()

  • Size: Male 13
MTM-13

  • Preformed vocal cord medialization implant
Size: Male 12
Boston Medical Products, Inc.
MTM-12
In Commercial Distribution

  • EBESMTM120 ()
  • EBESMTM121 ()

  • Size: Male 12
MTM-12

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

  • EBESMTM110 ()
  • EBESMTM111 ()

  • Size: Male 11
MTM-11

  • Preformed vocal cord medialization implant
Size: Male 10
Boston Medical Products, Inc.
MTM-10
In Commercial Distribution

  • EBESMTM100 ()
  • EBESMTM101 ()

  • Size: Male 10
MTM-10

  • Preformed vocal cord medialization implant
Size: Male 9
Boston Medical Products, Inc.
MTM-09
In Commercial Distribution

  • EBESMTM090 ()
  • EBESMTM091 ()

  • Size: Male 9
MTM-09

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

  • EBESMTM080 ()
  • EBESMTM081 ()

  • Size: Male 8
MTM-08

  • Preformed vocal cord medialization implant
Type: Male. Contains two each of MTM-08 & MTM-09. Contains four each of MTM-10, MTM-11, & MTM-12.
Boston Medical Products, Inc.
MTM-01
In Commercial Distribution

  • EBESMTM011 ()
MTM-01

  • 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 10
Boston Medical Products, Inc.
MTF-10
In Commercial Distribution

  • EBESMTF100 ()
  • EBESMTF101 ()

  • Size: Female 10
MTF-10

  • Preformed vocal cord medialization implant
Size: Female 9
Boston Medical Products, Inc.
MTF-09
In Commercial Distribution

  • EBESMTF090 ()
  • EBESMTF091 ()

  • Size: Female 9
MTF-09

  • 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 7
Boston Medical Products, Inc.
MTF-07
In Commercial Distribution

  • EBESMTF070 ()
  • EBESMTF071 ()

  • Size: Female 7
MTF-07

  • 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
Type: Combination. Contains one each of MTF-06, MTF-07, MTM-08, & MTM-09. Contains two each of MTF-08, MTF-09, MTF-10, MTM-10, MTM-11, & MTM-12.
Boston Medical Products, Inc.
MTC-01
In Commercial Distribution

  • EBESMTC011 ()
MTC-01

  • Preformed vocal cord medialization implant
Type: Male
Boston Medical Products, Inc.
MT-400
In Commercial Distribution

  • EBESMT4000 ()
  • EBESMT4001 ()
MT-400

  • Surgical implant template, single-use
Type: Female
Boston Medical Products, Inc.
MT-300
In Commercial Distribution

  • EBESMT3000 ()
  • EBESMT3001 ()
MT-300

  • Surgical implant template, single-use
Tray Only
Boston Medical Products, Inc.
MT-225
In Commercial Distribution

  • EBESMT2251 ()
MT-225

  • Instrument tray, reusable
Male Implant Inserter
Boston Medical Products, Inc.
MT-213
In Commercial Distribution

  • EBESMT2130 ()
MT-213

  • ENT elevator
Female Implant Inserter
Boston Medical Products, Inc.
MT-212
In Commercial Distribution

  • EBESMT2120 ()
MT-212

  • ENT elevator
Chisel Elevator
Boston Medical Products, Inc.
MT-211
In Commercial Distribution

  • EBESMT2110 ()
MT-211

  • ENT elevator
5 mm Duckbill Elevator
Boston Medical Products, Inc.
MT-210
In Commercial Distribution

  • EBESMT2100 ()
MT-210

  • ENT elevator
3 mm Duckbill Elevator
Boston Medical Products, Inc.
MT-209
In Commercial Distribution

  • EBESMT2090 ()
MT-209

  • ENT elevator
Large Sharp Hook
Boston Medical Products, Inc.
MT-208
In Commercial Distribution

  • EBESMT2080 ()
MT-208

  • ENT retractor
Small Sharp Hook
Boston Medical Products, Inc.
MT-207
In Commercial Distribution

  • EBESMT2070 ()
MT-207

  • ENT retractor
Large Curved Hook
Boston Medical Products, Inc.
MT-206
In Commercial Distribution

  • EBESMT2060 ()
MT-206

  • ENT retractor
Small Curved Hook
Boston Medical Products, Inc.
MT-205
In Commercial Distribution

  • EBESMT2050 ()
MT-205

  • ENT retractor
Male Outline Instrument
Boston Medical Products, Inc.
MT-204
In Commercial Distribution

  • EBESMT2040 ()
MT-204

  • Surgical implant template, reusable
Female Outline Instrument
Boston Medical Products, Inc.
MT-203
In Commercial Distribution

  • EBESMT2030 ()
MT-203

  • Surgical implant template, reusable
9 mm Male Window Caliper
Boston Medical Products, Inc.
MT-202
In Commercial Distribution

  • EBESMT2020 ()
MT-202

  • Surgical implant template, reusable
7 mm Female Window Caliper
Boston Medical Products, Inc.
MT-201
In Commercial Distribution

  • EBESMT2010 ()
MT-201

  • Surgical implant template, 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

  • EBESMT200P1 ()
MT-200P

  • ENT surgical procedure kit, non-medicated, single-use
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
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
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
DBX Mix, 20cc
Musculoskeletal Transplant Foundation, Inc.
058200
In Commercial Distribution

  • W4184058200T0474 ()

  • 20 cc volume
058200

  • Bone matrix implant, human-derived
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