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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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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
VersaWrap is an absorbable implant (device), designed to serve as an interface between target tissues and surrounding tissues to provide a non-constricting, protective encasement. VersaWrap consists of a clear Sheet and a wetting Solution. The clear Sheet is a thin membrane of crosslinked calcium alginate and glycosaminoglycan. VersaWrap Sheet is easy to handle, conformable, and is designed for placement under, around, or over injured tissues and/or surrounding tissues. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap Solution is applied to the Sheet to render the Sheet a gelatinous, tissue adherent layer (gel in situ). The aqueous citrate Solution is provided sterile, non-pyrogenic, for single use, in a dropper, packaged in a double peel pouch.
Alafair Biosciences, Inc.
VTP-1201
In Commercial Distribution

  • B454VTP12010 ()

  • Length: 1 Inch
  • Width: 2 Inch
  • Total Volume: 1 Milliliter
  • Length: 2.5 Centimeter
  • Width: 5 Centimeter
VTP-1201

  • Tendon spacer
  • Nerve guide, synthetic polymer, bioabsorbable
VersaWrap is an absorbable implant (device), designed to serve as an interface between target tissues and surrounding tissues to provide a non-constricting, protective encasement. VersaWrap consists of a clear Sheet and a wetting Solution. The clear Sheet is a thin membrane of crosslinked calcium alginate and glycosaminoglycan. VersaWrap Sheet is easy to handle, conformable, and is designed for placement under, around, or over injured tissues and/or surrounding tissues. VersaWrap Sheet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The VersaWrap Solution is applied to the Sheet to render the Sheet a gelatinous, tissue adherent layer (gel in situ). The aqueous citrate Solution is provided sterile, non-pyrogenic, for single use, in a dropper, packaged in a double peel pouch.
Alafair Biosciences, Inc.
VTP-2201
In Commercial Distribution

  • B454VTP22010 ()

  • Total Volume: 1 Milliliter
  • Length: 2 Inch
  • Width: 2 Inch
  • Length: 5 Centimeter
  • Width: 5 Centimeter
VTP-2201

  • Nerve guide, synthetic polymer, bioabsorbable
  • Tendon spacer
The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
IO 2B-D SA
In Commercial Distribution

  • 05712821006479 ()
  • 05712821008619 ()
N/a

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
IO 11B-A
In Commercial Distribution

  • 05712821006318 ()
  • 05712821009227 ()
N/a

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
IO 11A-D
In Commercial Distribution

  • 05712821006301 ()
  • 05712821009210 ()
N/a

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
IO 11A-C
In Commercial Distribution

  • 05712821006295 ()
  • 05712821009203 ()
N/a

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
IO 11A-B
In Commercial Distribution

  • 05712821006288 ()
  • 05712821009197 ()
N/a

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
IO 11A-A
In Commercial Distribution

  • 05712821006271 ()
  • 05712821009180 ()
N/a

  • Dental implant suprastructure, temporary, preformed, reusable
The Scan Body is manufactured from biocompatible titanium alloy (TiAl6V4 ELI) and polyetheretherketone (PEEK). The corresponding Scan Body Driver used to tighten the integrated screw is manufactured from biocompatible stainless steel. The product is available for a variety of implant platforms. For specific product descriptions, please refer to individual product labels.
Elos Medtech Pinol A/S
IO 10D-C
In Commercial Distribution

  • 05712821006264 ()
  • 05712821009173 ()
N/a

  • Dental implant suprastructure, temporary, preformed, reusable
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