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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 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
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
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
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
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
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
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
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
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
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
OSBA-005
In Commercial Distribution

  • 05060548020248 ()
OSBA-005

  • Bone matrix implant, synthetic, non-antimicrobial
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