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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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Angios Classic Angiographic Convenience Kit - 00885672101510

Angiographic Convenience Kit, 6F
Oscor Inc.
ANG4-0241
In Commercial Distribution

  • 00885672101510 ()

  • JL 4.0/110 cm, JR 4.0/110 cm, Straight Pigtail/120 cm
  • Guidewire - Length: 150 cm, OD: 0.035 in
  • Maximum Recommended Guidewire 0.038 in
  • Recommended Pressure Limit: 1200 psi max.
  • Adelante Sigma Introducer, 6F, Length: 10 cm, Needle 18 G, Syringe 10 cc
  • Pigtail Side Holes: 5
  • Flow Rate: JR: 32 mL/sec, JL: 32 mL/sec, PT: 35 mL/sec
  • Adelante Sigma Introducer Guidewire - Length: 50 cm, OD: 0.038 in
ANG4-0241

  • Angiographic catheter, single-use

Angios Classic Angiographic Convenience Kit - 00885672101480

Angiographic Convenience Kit, 6F
Oscor Inc.
ANG4-0041
In Commercial Distribution

  • 00885672101480 ()

  • Maximum Recommended Guidewire 0.038 in
  • Guidewire - Length: 150 cm, OD: 0.035 in
  • Recommended Pressure Limit: 1200 psi max.
  • Adelante Sigma Introducer Guidewire - Length: 50 cm, OD: 0.038 in
  • Pigtail Side Holes: 5
  • JL 4.0/100 cm, JR 4.0/100 cm, Straight Pigtail/110 cm
  • Flow Rate: JR: 33 mL/sec, JL: 34 mL/sec, PT: 36 mL/sec
  • Adelante Sigma Introducer, 6F, Length: 10 cm, Needle 18 G, Syringe 10 cc
ANG4-0041

  • Angiographic catheter, single-use

Angios Classic Angiographic Convenience Kit - 00885672101473

Angiographic Convenience Kit, 6F
Oscor Inc.
ANG4-0042
In Commercial Distribution

  • 00885672101473 ()

  • JL 4.0/100 cm, JR 4.0/100 cm, Pigtail 145°/110 cm
  • Adelante Sigma Introducer Guidewire - Length: 50 cm, OD: 0.038 in
  • Pigtail Side Holes: 5
  • Maximum Recommended Guidewire 0.038 in
  • Recommended Pressure Limit: 1200 psi max.
  • Guidewire - Length: 150 cm, OD: 0.035 in
  • Adelante Sigma Introducer, 6F, Length: 10 cm, Needle 18 G, Syringe 10 cc
  • Flow Rate: JR: 33 mL/sec, JL: 34 mL/sec, PT: 34 mL/sec
ANG4-0042

  • Angiographic catheter, single-use

Angios Classic Angiographic Convenience Kit - 00885672008734

Angiographic Convenience Kit, 6F
Oscor Inc.
ETANG4-0342
Not in Commercial Distribution

  • 00885672008734 ()

  • Flow Rate: JR: 33 mL/sec, JL: 34 mL/sec, PT: 34 mL/sec
  • Adelante Sigma Introducer Guidewire - Length: 50 cm, OD: 0.038 in
  • Maximum Recommended Guidewire 0.038 in
  • Pigtail Side Holes: 5
  • Guidewire - Length: 150 cm, OD: 0.035 in
  • Adelante Sigma Introducer, 6F, Length: 10 cm, Needle 18 G, Syringe 10 cc
  • Recommended Pressure Limit: 1200 psi max.
  • JL 4.0/100 cm, JR 4.0/100 cm, Pigtail 145°/110 cm
ETANG4-0342

  • Angiographic catheter, single-use

SIR-Spheres Y-90 resin microspheres - 00850014612146

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-Spheres Y-90 resin microspheres - 00850014612030

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

UNO 30 Therapy Kit 25x25 - 00849405011699

The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S2525-6
In Commercial Distribution

  • 00849405011699 ()


  • Negative-pressure wound therapy system, electric, single-use

UNO 30 Therapy Kit 20x25 - 00849405011682

The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S2025-6
In Commercial Distribution

  • 00849405011682 ()


  • Negative-pressure wound therapy system, electric, single-use

UNO 30 Therapy Kit 20x20 - 00849405011675

The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S2020-6
In Commercial Distribution

  • 00849405011675 ()


  • Negative-pressure wound therapy system, electric, single-use

UNO 30 Therapy Kit 15x30 - 00849405011668

The Genadyne UNO is a single use Negative Pressure Wound Therapy (NPWT) Unit designed for moderate to low severity wounds. The Genadyne UNO NPWT Unit has a pre-determined lifespan. The unit features an interface panel which provides alert and information signals and selectable therapy options. This unit provides negative pressure at either 80 mmHg or 125 mmHg, and offers selections of Continuous Mode at 80mmHg / 30mmHg or 125mmHg / 30mmHg in Variable Mode. The Genadyne UNO Therapy Kits include a therapy unit, 70 cc canisters, USB charger, USB cable and sterile dressing kits. Dressing kits and canisters for the Genadyne UNO could be provided separately. Dressing should be changed in line with standard wound dressing guidelines, typically every 3 days. More frequent changes may be required depending on level of exudate, condition of dressing, wound type/sizes, orientation of the dressing, environmental considerations or other patient considerations; e.g. when UNO is used on infected wounds.
GENADYNE BIOTECHNOLOGIES INC.
U-S1530-6
In Commercial Distribution

  • 00849405011668 ()


  • Negative-pressure wound therapy system, electric, single-use
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