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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 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
SCREW X0114222 CCM 4.75 XTAB 7.0X75
MEDTRONIC SOFAMOR DANEK, INC.
X0114222
In Commercial Distribution

  • 00643169544314 ()

  • DIA=7.0mm x L= 75mm


  • Spinal bone screw, non-bioabsorbable
Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 10cc suspended in a biocompatible hydrogel solution packed in two long cartridges ( 185 mm in length, inner diameter 6 mm, outer diameter 8 mm)sealed in a vacuum foil pouch. 185 mm long plunger & 100 mm short plunger sealed in a Tyvek pouch. Both foiled pouch & Tyvek pouch are sealed in an outer Tyvek pouch and then packed in a carton box.
BIOSTONE CO. LIMITED
SYS210M
In Commercial Distribution

  • 05060548020552 ()
SYS210M

  • 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 5cc suspended in a biocompatible hydrogel solution packed in one long cartridge ( 185 mm in length, inner diameter 6 mm, outer diameter 8 mm)sealed in a vacuum foil pouch. 185 mm long plunger & 100 mm short plunger sealed in a Tyvek pouch. Both foiled pouch & Tyvek pouch sealed in an outer Tyvek pouch. Then packed in a carton box.
BIOSTONE CO. LIMITED
SYS205M
In Commercial Distribution

  • 05060548020545 ()
SYS205M

  • Bone matrix implant, synthetic, non-antimicrobial
SCREW X0114220 CCM 4.75 XTAB 7.0X65
MEDTRONIC SOFAMOR DANEK, INC.
X0114220
In Commercial Distribution

  • 00643169544291 ()

  • DIA=7.0mm x L= 65mm


  • Spinal bone screw, non-bioabsorbable
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.
BIOSTONE CO. LIMITED
SYS205
In Commercial Distribution

  • 05060548020521 ()
SYS205

  • 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
SYS203
In Commercial Distribution

  • 05060548020514 ()
SYS203

  • Bone matrix implant, synthetic, non-antimicrobial
SCREW X0114218 CCM 4.75 XTAB 7.0X55
MEDTRONIC SOFAMOR DANEK, INC.
X0114218
In Commercial Distribution

  • 00643169544277 ()

  • DIA=7.0mm x L= 55mm


  • Spinal bone screw, non-bioabsorbable
SCREW X0114217 CCM 4.75 XTAB 7.0X50
MEDTRONIC SOFAMOR DANEK, INC.
X0114217
In Commercial Distribution

  • 00643169544260 ()

  • DIA=7.0mm x L= 50mm


  • Spinal bone screw, non-bioabsorbable
SCREW X0114216 CCM 4.75 XTAB 7.0X45
MEDTRONIC SOFAMOR DANEK, INC.
X0114216
In Commercial Distribution

  • 00643169544253 ()

  • DIA=7.0mm x L= 45mm


  • Spinal bone screw, non-bioabsorbable
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