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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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20G BACKFLUSH HPC BRUSH 6/B - 04058935005566

Single Use Medical Device for Ophthalmic Surgery
Bausch & Lomb GmbH
SUJ09
In Commercial Distribution

  • 24058935005560 ()
  • 04058935005566 ()
SUJ09

  • Vitrectomy fluid/gas handling handpiece/cannula

23G PASSIVE ASP HP W/SOFT TIP CAN.12B - 04058935005481

Single Use Medical Device for Ophthalmic Surgery
Bausch & Lomb GmbH
SUJ03
In Commercial Distribution

  • 24058935005485 ()
  • 04058935005481 ()
SUJ03

  • Vitrectomy fluid/gas handling handpiece/cannula

23G PASSIVE ASP HP W/SOFT TIP 12B - 04058935005443

Single Use Medical Device for Ophthalmic Surgery
Bausch & Lomb GmbH
SUJ01
In Commercial Distribution

  • 24058935005447 ()
  • 04058935005443 ()
SUJ01

  • Vitrectomy fluid/gas handling handpiece/cannula

25G Backflush/Extrusion Handpiece blunt 6/B - 04058935005665

Single Use Medical Device for Ophthalmic Surgery
Bausch & Lomb GmbH
SUJ14
In Commercial Distribution

  • 24058935005669 ()
  • 04058935005665 ()
SUJ14

  • Vitrectomy fluid/gas handling handpiece/cannula

20G BACKFLUSH HPC TUBE 6/B - 04058935005580

No Description
Bausch & Lomb GmbH
SUJ10
In Commercial Distribution

  • 24058935005584 ()
  • 04058935005580 ()
SUJ10

  • Vitrectomy fluid/gas handling handpiece/cannula

20G BACKFLUSH HPC BLUNT 6/B - 04058935005542

Single Use Medical Device for Ophthalmic Surgery
Bausch & Lomb GmbH
SUJ08
In Commercial Distribution

  • 24058935005546 ()
  • 04058935005542 ()
SUJ08

  • Vitrectomy fluid/gas handling handpiece/cannula

25G PASSIVE ASP HP W/SOFT TIP 12B - 04058935005467

Single Use Medical Device for Ophthalmic Surgery
Bausch & Lomb GmbH
SUJ02
In Commercial Distribution

  • 24058935005461 ()
  • 04058935005467 ()
SUJ02

  • Vitrectomy fluid/gas handling handpiece/cannula

Aperta NSE™ PTA Balloon Dilatation Catheter - 04543660026530

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 = 150mm, 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.
LA18-05060150
In Commercial Distribution

  • 04543660026530 ()
LA18-05060150

  • Peripheral angioplasty balloon catheter, basic

Aperta NSE™ PTA Balloon Dilatation Catheter - 04543660026523

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 = 100mm, 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.
LA18-05060100
In Commercial Distribution

  • 04543660026523 ()
LA18-05060100

  • Peripheral angioplasty balloon catheter, basic

Aperta NSE™ PTA Balloon Dilatation Catheter - 04543660026516

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 = 150mm, 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.
LA18-05050150
In Commercial Distribution

  • 04543660026516 ()
LA18-05050150

  • Peripheral angioplasty balloon catheter, basic
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