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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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Angiographic Convenience Kit, 5F
Oscor Inc.
ANG4-0040
In Commercial Distribution

  • 00885672101893 ()

  • Adelante Sigma Introducer, 5F, Length: 10 cm, Needle 18 G, Syringe 10 cc
  • Flow Rate: JR: 28 mL/sec, JL: 29 mL/sec, PT: 29 mL/sec
  • Adelante Sigma Introducer Guidewire - Length: 50 cm, OD: 0.038 in
  • Pigtail Side Holes: 5
  • Guidewire - Length: 150 cm, OD: 0.035 in
  • Recommended Pressure Limit: 1200 psi max.
  • Maximum Recommended Guidewire 0.038 in
  • JL 4.0/100 cm, JR 4.0/100 cm, Pigtail 145°/110 cm
ANG4-0040

  • Angiographic catheter, single-use
Angiographic Convenience Kit, 5F
Oscor Inc.
ANG4-0039
In Commercial Distribution

  • 00885672101886 ()

  • Maximum Recommended Guidewire 0.038 in
  • Guidewire - Length: 150 cm, OD: 0.035 in
  • Adelante Sigma Introducer, 5F, Length: 10 cm, Needle 18 G, Syringe 10 cc
  • Flow Rate: JR: 28 mL/sec, JL: 29 mL/sec, PT: 31 mL/sec
  • JL 4.0/100 cm, JR 4.0/100 cm, Straight Pigtail/110 cm
  • Pigtail Side Holes: 5
  • Recommended Pressure Limit: 1200 psi max.
  • Adelante Sigma Introducer Guidewire - Length: 50 cm, OD: 0.038 in
ANG4-0039

  • Angiographic catheter, single-use
Angiographic Convenience Kit, 4F
Oscor Inc.
ANG4-0238
Not in Commercial Distribution

  • 00885672101879 ()

  • Adelante Sigma Introducer Guidewire - Length: 50 cm, OD: 0.038 in
  • Maximum Recommended Guidewire 0.038 in
  • Recommended Pressure Limit: 1200 psi max.
  • JL 4.0/110 cm, JR 4.0/110 cm, Pigtail 145°/120 cm
  • Adelante Sigma Introducer, 4F, Length: 10 cm, Needle 18 G, Syringe 10 cc
  • Flow Rate: JR: 18 mL/sec, JL: 18 mL/sec, PT: 18 mL/sec
  • Pigtail Side Holes: 5
  • Guidewire - Length: 150 cm, OD: 0.035 in
ANG4-0238

  • Angiographic catheter, single-use
Angiographic Convenience Kit, 4F
Oscor Inc.
ANG4-0237
Not in Commercial Distribution

  • 00885672101862 ()

  • Flow Rate: JR: 18 mL/sec, JL: 18 mL/sec, PT: 19 mL/sec
  • Adelante Sigma Introducer, 4F, Length: 10 cm, Needle 18 G, Syringe 10 cc
  • Adelante Sigma Introducer Guidewire - Length: 50 cm, OD: 0.038 in
  • Maximum Recommended Guidewire 0.038 in
  • Guidewire - Length: 150 cm, OD: 0.035 in
  • JL 4.0/110 cm, JR 4.0/110 cm, Straight Pigtail/120 cm
  • Pigtail Side Holes: 5
  • Recommended Pressure Limit: 1200 psi max.
ANG4-0237

  • Angiographic catheter, single-use
Angiographic Convenience Kit, 4F
Oscor Inc.
ANG4-0038
Not in Commercial Distribution

  • 00885672101855 ()

  • Pigtail Side Holes: 5
  • Recommended Pressure Limit: 1200 psi max.
  • Guidewire - Length: 150 cm, OD: 0.035 in
  • JL 4.0/100 cm, JR 4.0/100 cm, Pigtail 145°/110 cm
  • Adelante Sigma Introducer, 4F, Length: 10 cm, Needle 18 G, Syringe 10 cc
  • Maximum Recommended Guidewire 0.038 in
  • Adelante Sigma Introducer Guidewire - Length: 50 cm, OD: 0.038 in
  • Flow Rate: JR: 18 mL/sec, JL: 19 mL/sec, PT: 19 mL/sec
ANG4-0038

  • Angiographic catheter, single-use
Angiographic Convenience Kit, 4F
Oscor Inc.
ANG4-0037
Not in Commercial Distribution

  • 00885672101848 ()

  • Guidewire - Length: 150 cm, OD: 0.035 in
  • Pigtail Side Holes: 5
  • Adelante Sigma Introducer Guidewire - Length: 50 cm, OD: 0.038 in
  • Flow Rate: JR: 18 mL/sec, JL: 19 mL/sec, PT: 20 mL/sec
  • Maximum Recommended Guidewire 0.038 in
  • JL 4.0/100 cm, JR 4.0/100 cm, Straight Pigtail/110 cm
  • Adelante Sigma Introducer, 4F, Length: 10 cm, Needle 18 G, Syringe 10 cc
  • Recommended Pressure Limit: 1200 psi max.
ANG4-0037

  • Angiographic catheter, single-use
Angiographic Convenience Kit, 6F
Oscor Inc.
ANG4-0242
In Commercial Distribution

  • 00885672101817 ()

  • Adelante Sigma Introducer, 6F, Length: 10 cm, Needle 18 G, Syringe 10 cc
  • Flow Rate: JR: 32 mL/sec, JL: 32 mL/sec, PT: 33 mL/sec
  • Adelante Sigma Introducer Guidewire - Length: 50 cm, OD: 0.038 in
  • Maximum Recommended Guidewire 0.038 in
  • Guidewire - Length: 150 cm, OD: 0.035 in
  • Pigtail Side Holes: 5
  • Recommended Pressure Limit: 1200 psi max.
  • JL 4.0/110 cm, JR 4.0/110 cm, Pigtail 145°/120 cm
ANG4-0242

  • Angiographic catheter, single-use
SIR-Y002 (1.8Gbq/3ml): SIR-Spheres Y-90 resin microspheres consist of biocompatible resin microspheres containing yttrium-90 with a size between 20 and 60 microns in diameter. Each vial contains 1.8 GBq of Y90 ± 10% (at the time of calibration) in a total of 3 cc water for injection. Yttrium-90 is a high-energy pure beta-emitting isotope with no primary gamma emission. The maximum energy of the beta particles is 2.27MeV with a mean of 0.93MeV. The maximum range of emissions in tissue is 11mm with a mean of 2.5mm. This is a brachytherapy product considered to be a sealed source device. The yttrium-90 has a purity specification of 999,900 ppm at reference, at (or after) time of manufacture of SIR-Spheres microspheres. The half-life is 64.1 hours. In use requiring the isotope to decay to infinity, 94% of the radiation is delivered in 11 days leaving only background radiation with no therapeutic value. SIR-Spheres microspheres themselves are a permanent implant. Each device is for single patient use.
SIRTEX MEDICAL PTY LTD
SIR-Y002
In Commercial Distribution

  • 00850014612146 ()

  • Total Volume: 3 Milliliter


  • Manual brachytherapy source, permanent implant
SIR-Y001 (3Gbq/5ml): SIR-Spheres Y-90 resin microspheres consist of biocompatible resin microspheres containing yttrium-90 with a size between 20 and 60 microns in diameter. Each vial contains 3 GBq of Y90 ± 10% (at the time of calibration) in a total of 5 cc water for injection. Yttrium-90 is a high-energy pure beta-emitting isotope with no primary gamma emission. The maximum energy of the beta particles is 2.27MeV with a mean of 0.93MeV. The maximum range of emissions in tissue is 11mm with a mean of 2.5mm. This is a brachytherapy product considered to be a sealed source device. The yttrium-90 has a purity specification of 999,900 ppm at reference, at (or after) time of manufacture of SIR-Spheres microspheres. The half-life is 64.1 hours. In use requiring the isotope to decay to infinity, 94% of the radiation is delivered in 11 days leaving only background radiation with no therapeutic value. SIR-Spheres microspheres themselves are a permanent implant. Each device is for single patient use.
SIRTEX MEDICAL PTY LTD
SIR-Y001
In Commercial Distribution


  • Total Volume: 5 Milliliter


  • Manual brachytherapy source, permanent implant
SIR-Y001 (3Gbq/5ml): SIR-Spheres Y90 resin microspheres consist of biocompatible resin microspheres containing yttrium-90 with a size between 20 and 60 microns in diameter. Each vial contains 3 GBq of Y90 ± 10% (at the time of calibration) in a total of 5 cc water for injection. Yttrium-90 is a high-energy pure beta-emitting isotope with no primary gamma emission. The maximum energy of the beta particles is 2.27MeV with a mean of 0.93MeV. The maximum range of emissions in tissue is 11mm with a mean of 2.5mm. This is a brachytherapy product considered to be a sealed source device. The yttrium-90 has a purity specification of 999,900 ppm at reference, at (or after) time of manufacture of SIR-Spheres microspheres. The half-life is 64.1 hours. In use requiring the isotope to decay to infinity, 94% of the radiation is delivered in 11 days leaving only background radiation with no therapeutic value. SIR-Spheres microspheres themselves are a permanent implant. Each device is for single patient use.
SIRTEX MEDICAL PTY LTD
SIR-Y001
Not in Commercial Distribution

  • M425SIRY0010 ()

  • Total Volume: 5 Milliliter


  • Manual brachytherapy source, permanent implant
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