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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 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
The Exsudex® Disposable Canister, commercially labelled as CCT Mini Disposable Canister, has the following features and is only to be used together with the NewERA II wound drainage system: - Canister capacity 300 cc; - Bacterial filter; - Fixed non-sterile suction tube, 157.5 cm, with clamb and luer-lock connector - Dissolving sachet solidifying agent
Meditop B.V.
CCT Mini disposable canister with tube and luer-lock connector
In Commercial Distribution

  • 08718104890480 ()
16690-LLA

  • Surgical suction system collection container, single-use
The Exsudex® Disposable Canister, commercially labelled as CCT 1 Disposable Canister, has the following features and is only to be used together with the NewERA II wound drainage system: - Canister capacity 900 cc; - Bacterial filter; - Fixed non-sterile suction tube, 157.5 cm, with clamb and luer-lock connector - Dissolving sachet solidifying agent
Meditop B.V.
CCT 1 disposable canister with tube and luer-lock connector
In Commercial Distribution

  • 08718104890473 ()
16670-LLA

  • Surgical suction system collection container, single-use
Introducer Set with Hemostatic Valve, 11F
Oscor Inc.
ASGAT11016
In Commercial Distribution

  • 00836559007050 ()

  • Sheath Length 16 cm
  • Radiopaque Tip
  • Dilator Length 21 cm
  • Needle Gauge: 18 Gauge
  • Guidewire Length 50 cm
  • Lumen/Inner Diameter: 3.8 Millimeter
  • Guidewire Diameter 0.035 in
  • Syringe 10 cc


  • Vascular catheter introduction set, nonimplantable
Introducer set with hemostatic valve, 9F
Oscor Inc.
DYNJINTROL9
Not in Commercial Distribution

  • 20889942000361 ()
  • 10889942000364 ()

  • Sheath Length 23 cm
  • Needle 18 G
  • Dilator Length 28 cm
  • Guidewire Length: 50 cm, OD: 0.038 in
  • Syringe 10 cc
  • Lumen/Inner Diameter: 3 Millimeter
DYNJINTROL9

  • Vascular catheter introduction set, nonimplantable
Introducer set with hemostatic valve, 8F
Oscor Inc.
DYNJINTROL8
Not in Commercial Distribution

  • 20889942000354 ()
  • 10889942000357 ()

  • Syringe 10 cc
  • Guidewire Length: 50 cm, OD: 0.038 in
  • Dilator Length 28 cm
  • Lumen/Inner Diameter: 2.7 Millimeter
  • Sheath Length 23 cm
  • Needle 18 G
DYNJINTROL8

  • Vascular catheter introduction set, nonimplantable
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
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