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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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Porcelain Repair Kit (Green) - D7796610053

Porcelain Repair Kit (Green) includes 1 (2.5 cc) PorcelETCH™ Green, 3 of 25-gauge Blue Luer Lock Tips, 1 (10 mL) Bottle of Silanator™, 1 (3 g) GINGA-Guard syringe, 3 of White nozzle, 3 of 16 gauge Black Luer Lock Tips, 1 (2.5 g) Creative Color Opaquer Pink syringe, 1 Cosmedent #1 brush, and 1 (6 mL) Complete Primer/Unfilled Resin (Red Cap) in the Tray.
COSMEDENT, INC.
661005
In Commercial Distribution

  • D7796610053 ()
661005

  • Dental repair kit, ceramic

Trigon - 00810005669429

Instrument: CC Wedge 14mm Trial. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-2514T-CC
In Commercial Distribution

  • 00810005669429 ()

  • 14mm, Thick
  • Width: 25 Millimeter


  • Orthopaedic inorganic implant inserter/extractor, reusable

Trigon - 00810005669412

Instrument: CC Wedge 12mm Trial. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-2512T-CC
In Commercial Distribution

  • 00810005669412 ()

  • 12mm, Thick
  • Width: 25 Millimeter


  • Orthopaedic inorganic implant inserter/extractor, reusable

Trigon - 00810005669405

Instrument: CC Wedge 10mm Trial. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-2510T-CC
In Commercial Distribution

  • 00810005669405 ()

  • 10mm, Thick
  • Width: 25 Millimeter


  • Orthopaedic inorganic implant inserter/extractor, reusable

Trigon - 00810005669399

Instrument: CC Wedge 8mm Trial. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-2508T-CC
In Commercial Distribution

  • 00810005669399 ()

  • 8mm, Thick
  • Width: 25 Millimeter


  • Orthopaedic inorganic implant inserter/extractor, reusable

Trigon - 00810005669337

Implant PEEK CC Wedge, 14mm. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
CC-2525-14
In Commercial Distribution

  • 00810005669337 ()

  • Width: 25 Millimeter
  • Depth: 25 Millimeter
  • 14mm Thick


  • Polymeric osteotomy fusion cage, non-customized

Trigon - 00810005669320

Implant PEEK CC Wedge, 12mm. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
CC-2525-12
In Commercial Distribution

  • 00810005669320 ()

  • Width: 25 Millimeter
  • Depth: 25 Millimeter
  • 12mm Thick


  • Polymeric osteotomy fusion cage, non-customized

Trigon - 00810005669313

Implant PEEK CC Wedge, 10mm. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
CC-2525-10
In Commercial Distribution

  • 00810005669313 ()

  • Width: 25 Millimeter
  • Depth: 25 Millimeter
  • 10mm Thick


  • Polymeric osteotomy fusion cage, non-customized

Trigon - 00810005669306

Implant PEEK CC Wedge, 8mm. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
CC-2525-08
In Commercial Distribution

  • 00810005669306 ()

  • Width: 25 Millimeter
  • Depth: 25 Millimeter
  • 8mm Thick


  • Polymeric osteotomy fusion cage, non-customized

Trigon - 00814008029785

Instrument: CC Wedge Inserter. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-1001T-CCI
In Commercial Distribution

  • 00814008029785 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable
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