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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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BioViveSBG - 05060548020378

Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 3 cc suspended in a biocompatible hydrogel solution packed in a 14ml open bore syringe. They are packed in a vacuum sealed foil inner pouch within a Tyvek outer pouch and packed in a carton box
BIOSTONE CO. LIMITED
1DE-OBS-03
In Commercial Distribution

  • 05060548020378 ()
1DE-OBS-03

  • Bone matrix implant, synthetic, non-antimicrobial

si_Mochi - 05060548020101

Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 3 cc suspended in a biocompatible hydrogel solution packed in a 14ml open bore syringe. They are packed in a vacuum sealed foil inner pouch within a Tyvek outer pouch and packed in a carton box
BIOSTONE CO. LIMITED
OBS1203
In Commercial Distribution

  • 05060548020101 ()
OBS1203

  • Bone matrix implant, synthetic, non-antimicrobial

si-Mochi - 05060548020569

Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 3 cc suspended in a dried biocompatible hydrogel solution packed in a 14ml open bore syringe. They are packed in a vacuum sealed foil inner pouch within a Tyvek outer pouch and packed in a carton box
BIOSTONE CO. LIMITED
XOBS1203
In Commercial Distribution

  • 05060548020569 ()
XOBS1203

  • Bone matrix implant, synthetic, non-antimicrobial

si_Mochi - 05060548020163

Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 2 cc suspended in a biocompatible hydrogel solution packed in a 14ml open bore syringe. They are packed in a vacuum-sealed foil inner pouch within a Tyvek outer pouch and packed in a carton box. Animal Only
BIOSTONE CO. LIMITED
VET1210-O
In Commercial Distribution

  • 05060548020163 ()
VET1210-O

  • Bone matrix implant, synthetic, non-antimicrobial

si_Mochi - 05060548020156

Silica-induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 5 cc suspended in a biocompatible hydrogel solution packed in a 14ml open bore syringe. They are packed in a vacuum-sealed foil inner pouch within a Tyvek outer pouch and packed in a carton box. Animal use only
BIOSTONE CO. LIMITED
VET1205-O
In Commercial Distribution

  • 05060548020156 ()
VET1205-O

  • Bone matrix implant, synthetic, non-antimicrobial

si_Mochi - 05060548020149

Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 3 cc suspended in a biocompatible hydrogel solution packed in a 14ml open bore syringe. They are packed in a vacuum-sealed foil inner pouch within a Tyvek outer pouch and packed in a carton box. Animal use only
BIOSTONE CO. LIMITED
VET1203-O
In Commercial Distribution

  • 05060548020149 ()
VET1203-O

  • Bone matrix implant, synthetic, non-antimicrobial

si-Mochi - 05060548020576

Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 5 cc suspended in a dried biocompatible hydrogel solution packed in a 14ml open bore syringe. They are packed in a vacuum sealed foil inner pouch within a Tyvek outer pouch and packed in a carton box
BIOSTONE CO. LIMITED
XOBS1205
In Commercial Distribution

  • 05060548020576 ()
XOBS1205

  • Bone matrix implant, synthetic, non-antimicrobial

si_Mochi - 05060548020132

Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 2 cc suspended in a biocompatible hydrogel solution packed in a capped 10 cm cartridge with a sealed O-ring plunger. They are packed in a vacuum-sealed foil inner pouch within a Tyvek outer pouch and packed in a carton box. Animal use only
BIOSTONE CO. LIMITED
VET1202-O
In Commercial Distribution

  • 05060548020132 ()
VET1202-O

  • Synthetic bone graft

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
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