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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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OsteoXcell BA - 05060548020255

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

OsteoXcell BA - 05060548020231

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

si_Mochi - 05060548020125

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

si_Mochi - 05060548020101

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

si_Mochi - 05060548020019

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

Plastic Conditioner - D798PL0

The Reliance Plastic Appliance Conditioner is intended for use as a conditioner of plastic brackets or acrylic appliances in preparation for bonding with any adhesive, sealant or cement. It can also be used to condition a composite restoration or acrylic jacket prior to bonding and to rebond a bracket impregnated with adhesive. 10 cc bottle
RELIANCE ORTHODONTIC PRODUCTS INC
PL
In Commercial Distribution

  • D798PL0 ()
PL

  • Dentine bonding agent/set

si-Mochi - 05060548020576

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

si-Mochi - 05060548020569

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

si_Mochi - 05060548020163

Silica induced bi-phase calcium phosphate ceramic morsels, 80% HA and 20% beta-TCP size 1 to 2mm volume 2 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 Only
BIOSTONE CO. LIMITED
VET1210-O
In Commercial Distribution

  • 05060548020163 ()
VET1210-O

  • Bone matrix implant, synthetic, non-antimicrobial

si_Mochi - 05060548020156

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. Animal use only
BIOSTONE CO. LIMITED
VET1205-O
In Commercial Distribution

  • 05060548020156 ()
VET1205-O

  • Bone matrix implant, synthetic, non-antimicrobial
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