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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
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 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
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
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
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
No Description
ACRE PHARMA LIMITED
N/A
In Commercial Distribution

  • 05060604130102 ()


  • Dermal tissue reconstructive material, animal-derived
No Description
ACRE PHARMA LIMITED
N/A
In Commercial Distribution

  • 05060604130096 ()


  • Dermal tissue reconstructive material, animal-derived
No Description
ACRE PHARMA LIMITED
N/A
In Commercial Distribution

  • 05060604130072 ()


  • Dermal tissue reconstructive material, animal-derived
No Description
ACRE PHARMA LIMITED
N/A
In Commercial Distribution

  • 05060604130041 ()
  • 05060604130058 ()


  • Synovial fluid supplementation medium
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