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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, 5F
Oscor Inc.
DYNJINTROL5
Not in Commercial Distribution

  • 40888277000019 ()
  • 00888277000011 ()

  • Sheath Length 23 cm
  • Syringe 10 cc
  • Dilator Length 28 cm
  • Guidewire Length: 50 cm, OD: 0.038 in
  • Needle 18 G
  • Lumen/Inner Diameter: 1.9 Millimeter
DYNJINTROL5

  • Vascular catheter introduction set, nonimplantable
Introducer set with hemostatic valve, 4F
Oscor Inc.
DYNJINTROL4
Not in Commercial Distribution

  • 40888277000002 ()
  • 00888277000004 ()

  • Needle 18 G
  • Guidewire Length: 50 cm, OD: 0.038 in
  • Sheath Length 23 cm
  • Dilator Length 28 cm
  • Lumen/Inner Diameter: 1.4 Millimeter
  • Syringe 10 cc
DYNJINTROL4

  • 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
Introducer set with hemostatic valve, 12F
Oscor Inc.
DYNJINTROL12
Not in Commercial Distribution

  • 20889942000286 ()
  • 10889942000289 ()

  • Guidewire Length: 50 cm, OD: 0.038 in
  • Lumen/Inner Diameter: 4 Millimeter
  • Needle 18 G
  • Dilator Length 28 cm
  • Sheath Length 23 cm
  • Syringe 10 cc
DYNJINTROL12

  • Vascular catheter introduction set, nonimplantable
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
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
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