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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, 10F
Oscor Inc.
DYNJINTROL10
Not in Commercial Distribution

  • 20889942000217 ()
  • 10889942000210 ()

  • Sheath Length 23 cm
  • Syringe 10 cc
  • Dilator Length 28 cm
  • Guidewire Length: 50 cm, OD: 0.038 in
  • Lumen/Inner Diameter: 3.4 Millimeter
  • Needle 18 G
DYNJINTROL10

  • Vascular catheter introduction set, nonimplantable
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
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 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 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
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
Introducer set with hemostatic valve, 6F
Oscor Inc.
DYNJINTROR6
Not in Commercial Distribution

  • 40888277000712 ()
  • 00888277000714 ()

  • Guidewire Length: 45 cm, OD: 0.018 in
  • Sheath Length 10 cm
  • Syringe 10 cc
  • Needle 21 G, 4 cm
  • Dilator Length 15 cm
  • Lumen/Inner Diameter: 2.1 Millimeter
DYNJINTROR6

  • Vascular catheter introduction set, nonimplantable
Introducer set with hemostatic valve, 5F
Oscor Inc.
DYNJINTROR5
Not in Commercial Distribution

  • 40888277000705 ()
  • 00888277000707 ()

  • Guidewire Length: 45 cm, OD: 0.018 in
  • Dilator Length 15 cm
  • Lumen/Inner Diameter: 1.9 Millimeter
  • Syringe 10 cc
  • Sheath Length 10 cm
  • Needle 21 G, 4 cm
DYNJINTROR5

  • Vascular catheter introduction set, nonimplantable
Introducer set with hemostatic valve, 4F
Oscor Inc.
DYNJINTROR4
Not in Commercial Distribution

  • 40888277000699 ()
  • 00888277000691 ()

  • Lumen/Inner Diameter: 1.5 Millimeter
  • Syringe 10 cc
  • Needle 21 G, 4 cm
  • Dilator Length 15 cm
  • Guidewire Length: 45 cm, OD: 0.018 in
  • Sheath Length 10 cm
DYNJINTROR4

  • Vascular catheter introduction set, nonimplantable
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
SYS210
In Commercial Distribution

  • 05060548020538 ()
SYS210

  • Bone matrix implant, synthetic, non-antimicrobial
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