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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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Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 10 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
OSBA-010
In Commercial Distribution

  • 05060548020255 ()
OSBA-010

  • Bone matrix implant, synthetic, non-antimicrobial
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
OSBA-003
In Commercial Distribution

  • 05060548020231 ()
OSBA-003

  • Bone matrix implant, synthetic, non-antimicrobial
Silica-induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 1 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
BIOSTONE CO. LIMITED
VET1201-O
In Commercial Distribution

  • 05060548020125 ()
VET1201-O

  • Bone matrix implant, synthetic, non-antimicrobial
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
Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 10 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
OBS1210
In Commercial Distribution

  • 05060548020019 ()
OBS1210

  • Bone matrix implant, synthetic, non-antimicrobial
Introducer set with hemostatic valve, 6F
Oscor Inc.
DYNJINTROR6
Not in Commercial Distribution

  • 40888277000712 ()
  • 00888277000714 ()

  • Guidewire Length: 45 cm, OD: 0.018 in
  • Sheath Length 10 cm
  • Syringe 10 cc
  • Needle 21 G, 4 cm
  • Dilator Length 15 cm
  • Lumen/Inner Diameter: 2.1 Millimeter
DYNJINTROR6

  • Vascular catheter introduction set, nonimplantable
Introducer set with hemostatic valve, 5F
Oscor Inc.
DYNJINTROR5
Not in Commercial Distribution

  • 40888277000705 ()
  • 00888277000707 ()

  • Guidewire Length: 45 cm, OD: 0.018 in
  • Dilator Length 15 cm
  • Lumen/Inner Diameter: 1.9 Millimeter
  • Syringe 10 cc
  • Sheath Length 10 cm
  • Needle 21 G, 4 cm
DYNJINTROR5

  • Vascular catheter introduction set, nonimplantable
Introducer set with hemostatic valve, 4F
Oscor Inc.
DYNJINTROR4
Not in Commercial Distribution

  • 40888277000699 ()
  • 00888277000691 ()

  • Lumen/Inner Diameter: 1.5 Millimeter
  • Syringe 10 cc
  • Needle 21 G, 4 cm
  • Dilator Length 15 cm
  • Guidewire Length: 45 cm, OD: 0.018 in
  • Sheath Length 10 cm
DYNJINTROR4

  • Vascular catheter introduction set, nonimplantable
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
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
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