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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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System 2 BA - 05060548020514

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

System 2 BA - 05060548020507

Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 2cc, suspended in a biocompatible hydrogel solution packed in a 3 ml open bore syringes. Packed in a vacuum sealed foil inner pouch within a Tyvek outer pouch. Packed in a carton box.
BIOSTONE CO. LIMITED
SYS202
In Commercial Distribution

  • 05060548020507 ()
SYS202

  • Bone matrix implant, synthetic, non-antimicrobial

System 2 BA - 05060548020491

Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 1cc, suspended in a biocompatible hydrogel solution packed in a 3 ml open bore syringes. Packed in a vacuum sealed foil inner pouch within a Tyvek outer pouch. Packed in a carton box.
BIOSTONE CO. LIMITED
SYS201
In Commercial Distribution

  • 05060548020491 ()
SYS201

  • Bone matrix implant, synthetic, non-antimicrobial

Apex ASG - 05060548020484

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
966-1210
In Commercial Distribution

  • 05060548020484 ()
966-1210

  • Bone matrix implant, synthetic, non-antimicrobial

Apex ASG - 05060548020477

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
966-1205
In Commercial Distribution

  • 05060548020477 ()
966-1205

  • Bone matrix implant, synthetic, non-antimicrobial

Apex ASG - 05060548020460

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
965-1210
In Commercial Distribution

  • 05060548020460 ()
965-1210

  • Bone matrix implant, synthetic, non-antimicrobial

Apex ASG - 05060548020453

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
965-1205
In Commercial Distribution

  • 05060548020453 ()
965-1205

  • Bone matrix implant, synthetic, non-antimicrobial

Apex ASG - 05060548020446

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
965-1203
In Commercial Distribution

  • 05060548020446 ()
965-1203

  • Bone matrix implant, synthetic, non-antimicrobial

Apex ASG - 05060548020439

Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 2cc, suspended in a biocompatible hydrogel solution packed in a 3 ml open bore syringes. Packed in a vacuum sealed foil inner pouch within a Tyvek outer pouch. Packed in a carton box.
BIOSTONE CO. LIMITED
965-1202
In Commercial Distribution

  • 05060548020439 ()
965-1202

  • Bone matrix implant, synthetic, non-antimicrobial

Apex ASG - 05060548020422

Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 1cc, suspended in a biocompatible hydrogel solution packed in a 3 ml open bore syringes. Packed in a vacuum sealed foil inner pouch within a Tyvek outer pouch. Packed in a carton box.
BIOSTONE CO. LIMITED
965-1201
In Commercial Distribution

  • 05060548020422 ()
965-1201

  • Bone matrix implant, synthetic, non-antimicrobial
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