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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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Introducer set with hemostatic valve - 20889942000347

Introducer set with hemostatic valve, 7F
Oscor Inc.
DYNJINTROL7
Not in Commercial Distribution

  • 20889942000347 ()
  • 10889942000340 ()

  • Lumen/Inner Diameter: 2.4 Millimeter
  • Needle 18 G
  • Sheath Length 23 cm
  • Guidewire Length: 50 cm, OD: 0.038 in
  • Syringe 10 cc
  • Dilator Length 28 cm
DYNJINTROL7

  • Vascular catheter introduction set, nonimplantable

Introducer set with hemostatic valve - 20889942000279

Introducer set with hemostatic valve, 11F
Oscor Inc.
DYNJINTROL11
Not in Commercial Distribution

  • 20889942000279 ()
  • 10889942000272 ()

  • Syringe 10 cc
  • Lumen/Inner Diameter: 3.7 Millimeter
  • Needle 18 G
  • Guidewire Length: 50 cm, OD: 0.038 in
  • Sheath Length 23 cm
  • Dilator Length 28 cm
DYNJINTROL11

  • Vascular catheter introduction set, nonimplantable

System 2 BA - 05060548020521

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
SYS205
In Commercial Distribution

  • 05060548020521 ()
SYS205

  • 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

OsteoXcell BA - 05060548020248

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

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

si_Mochi - 05060548020002

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
OBS1205
In Commercial Distribution

  • 05060548020002 ()
OBS1205

  • Bone matrix implant, synthetic, non-antimicrobial

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

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

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
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