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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 - 05060548020415

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
1DE-MIS-10
In Commercial Distribution

  • 05060548020415 ()
1DE-MIS-10

  • Bone matrix implant, synthetic, non-antimicrobial

BioViveSBG - 05060548020408

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
1DE-MIS-05
In Commercial Distribution

  • 05060548020408 ()
1DE-MIS-05

  • Bone matrix implant, synthetic, non-antimicrobial

BioViveSBG - 05060548020392

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
1DE-OBS-10
In Commercial Distribution

  • 05060548020392 ()
1DE-OBS-10

  • Bone matrix implant, synthetic, non-antimicrobial

BioViveSBG - 05060548020385

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
1DE-OBS-05
In Commercial Distribution

  • 05060548020385 ()
1DE-OBS-05

  • Bone matrix implant, synthetic, non-antimicrobial

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

BioViveSBG - 05060548020361

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
1DE-OBS-02
In Commercial Distribution

  • 05060548020361 ()
1DE-OBS-02

  • Bone matrix implant, synthetic, non-antimicrobial

BioViveSBG - 05060548020354

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
1DE-OBS-01
In Commercial Distribution

  • 05060548020354 ()
1DE-OBS-01

  • Bone matrix implant, synthetic, non-antimicrobial

SynthaGen HaTCP - 05060548020347

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
MIS-1210-FO
In Commercial Distribution

  • 05060548020347 ()
MIS-1210-FO

  • Bone matrix implant, synthetic, non-antimicrobial

SynthaGen HaTCP - 05060548020330

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
MIS-1205-FO
In Commercial Distribution

  • 05060548020330 ()
MIS-1205-FO

  • Bone matrix implant, synthetic, non-antimicrobial

SynthaGen HaTCP - 05060548020293

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
OBS-1202-FO
In Commercial Distribution

  • 05060548020293 ()
OBS-1202-FO

  • Bone matrix implant, synthetic, non-antimicrobial
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