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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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The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 4.0mm, Length = 40mm, Minimum Introducer Sheath = 5F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
GOODMAN CO.,LTD.
AW18-05040040
In Commercial Distribution

  • 04543660025694 ()
AW18-05040040

  • Peripheral angioplasty balloon catheter, basic
The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 14atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 8.0mm, Length = 40mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
GOODMAN CO.,LTD.
AA18-05080040
In Commercial Distribution

  • 04543660025632 ()
AA18-05080040

  • Peripheral angioplasty balloon catheter, basic
The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 14atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 7.0mm, Length = 40mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
GOODMAN CO.,LTD.
AA18-05070040
In Commercial Distribution

  • 04543660025625 ()
AA18-05070040

  • Peripheral angioplasty balloon catheter, basic
The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 6.0mm, Length = 40mm, Minimum Introducer Sheath = 6F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
GOODMAN CO.,LTD.
AA18-05060040
In Commercial Distribution

  • 04543660025618 ()
AA18-05060040

  • Peripheral angioplasty balloon catheter, basic
The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 5.0mm, Length = 40mm, Minimum Introducer Sheath = 5F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
GOODMAN CO.,LTD.
AA18-05050040
In Commercial Distribution

  • 04543660025601 ()
AA18-05050040

  • Peripheral angioplasty balloon catheter, basic
The Aperta NSE PTA is a peripheral cutting/scoring NC balloon with 4 nylon elements to reduce slippage during inflation. Nominal Pressure = 10atm, Rated Burst Pressure = 20atm, Guide Wire Compatibility = 0.018” OTW, Shaft Length = 50cm, Diameter = 4.0mm, Length = 40mm, Minimum Introducer Sheath = 5F. The Aperta NSE PTA Balloon Dilatation Catheter is indicated for percutaneous transluminal angioplasty (PTA) of lesions in peripheral arteries, including iliac, femoral, ilio-femoral, popliteal and infra-popliteal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for treatment of in-stent restenosis of balloon expandable and self-expanding stents in the peripheral vasculature. This device is not for use in the coronary or neuro-vasculature including carotid arteries.
GOODMAN CO.,LTD.
AA18-05040040
In Commercial Distribution

  • 04543660025595 ()
AA18-05040040

  • Peripheral angioplasty balloon catheter, basic
25G x 6"(152mm) Metal hub With 1cm calibrations, depth guide
HAKKO CO.,LTD.
XN152-25
In Commercial Distribution

  • 14526737170555 ()
  • 04526737170558 ()

  • Needle Gauge: 25 Gauge
  • Length: 152 Millimeter


  • Peripheral nerve-block sharp needle
25G x 5 1/2"(140mm) Metal hub With 1cm calibrations, depth guide
HAKKO CO.,LTD.
XN140-25
In Commercial Distribution

  • 14526737170548 ()
  • 04526737170541 ()

  • Needle Gauge: 25 Gauge
  • Length: 140 Millimeter


  • Peripheral nerve-block sharp needle
25G x 4 3/4"(121mm) Metal hub With 1cm calibrations, depth guide
HAKKO CO.,LTD.
XN120-25
In Commercial Distribution

  • 14526737170531 ()
  • 04526737170534 ()

  • Needle Gauge: 25 Gauge
  • Length: 121 Millimeter


  • Peripheral nerve-block sharp needle
22G x 12"(305mm) Metal hub With 1cm calibrations, depth guide
HAKKO CO.,LTD.
XN305-22
In Commercial Distribution

  • 14526737170524 ()
  • 04526737170527 ()

  • Needle Gauge: 22 Gauge
  • Length: 305 Millimeter


  • Peripheral nerve-block sharp needle
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