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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Size #4, Silicone Reusable (50 times) Laryngeal Mask EndoMask Elite® is our high quality reusable silicone laryngeal mask that may be cleaned and sterilized for up to 50 uses. Elite® comprises a soft smooth cuff and a soft, pliable tube body. The product is packaged in individual sterile pouches, 5 units per carton. Each Elite® mask is uniquely numbered and comes with a tracking card with that same unique number for easy tracking of each use and re-use after cleaning and sterilization by steam autoclave process. Elite® has a superior inflatable cuff that conforms to the natural contours of the hypopharynx for perfect fit. Our cuff and tube assembly enables rapid, blind insertion, excellent seal, and single-hand ventilation. The seam around the outside of the inflatable cuff is smooth while the seam of most competitors is often rough and can cause irritation. Our cuff assembly and tube body is smoother and has less voids and impurities within its structure then other silicone laryngeal masks. There are no epiglottic bar (aperture bar) obstructions enabling easy access for a fiberscope and suction catheters. Only medical grade silicone polymers are used in the manufacture of EndoMask® products. Manufacture of EndoMask Elite® is under the strictest quality control and sterile conditions. All EndoMask® products utilize 100 percent latex free manufacturing and packaging materials.
MERLYN ASSOCIATES, INC.
Size #4 - 280040
In Commercial Distribution

  • 00182151000013 ()
  • 10182151000010 ()
280040

  • Oropharyngeal airway, reusable
Size #5, Silicone Reusable (50 times) Laryngeal Mask EndoMask Elite® is our high quality reusable silicone laryngeal mask that may be cleaned and sterilized for up to 50 uses. Elite® comprises a soft smooth cuff and a soft, pliable tube body. The product is packaged in individual sterile pouches, 5 units per carton. Each Elite® mask is uniquely numbered and comes with a tracking card with that same unique number for easy tracking of each use and re-use after cleaning and sterilization by steam autoclave process. Elite® has a superior inflatable cuff that conforms to the natural contours of the hypopharynx for perfect fit. Our cuff and tube assembly enables rapid, blind insertion, excellent seal, and single-hand ventilation. The seam around the outside of the inflatable cuff is smooth while the seam of most competitors is often rough and can cause irritation. Our cuff assembly and tube body is smoother and has less voids and impurities within its structure then other silicone laryngeal masks. There are no epiglottic bar (aperture bar) obstructions enabling easy access for a fiberscope and suction catheters. Only medical grade silicone polymers are used in the manufacture of EndoMask® products. Manufacture of EndoMask Elite® is under the strictest quality control and sterile conditions. All EndoMask® products utilize 100 percent latex free manufacturing and packaging materials.
MERLYN ASSOCIATES, INC.
Size #5 - 280050
In Commercial Distribution

  • 10182151000003 ()
  • 00182151000006 ()
280050

  • Oropharyngeal airway, reusable
BO-RF32 Rotaflow
DATASCOPE CORP.
BO-T 6600
Not in Commercial Distribution

  • 00607567203952 ()
701052324

  • Cardiopulmonary bypass system centrifugal pump
Turbo-Power™ Laser Atherectomy Catheter
Spectranetics Corporation
423-050AA
In Commercial Distribution

  • 00813132025397 ()

  • Outer Diameter: 2.3 Millimeter
423-050

  • Atherectomy laser system beam guide-catheter, peripheral
Turbo-Power™ Laser Atherectomy Catheter
Spectranetics Corporation
420-050AA
In Commercial Distribution

  • 00813132025366 ()

  • Outer Diameter: 2.0 Millimeter
420-050

  • Atherectomy laser system beam guide-catheter, peripheral
Turbo-Power™ Laser Atherectomy Catheter
Spectranetics Corporation
420-050
In Commercial Distribution

  • 00813132024833 ()

  • Outer Diameter: 2.0 Millimeter
420-050

  • Atherectomy laser system beam guide-catheter, peripheral
Turbo-Power™ Laser Atherectomy Catheter
Spectranetics Corporation
423-050
In Commercial Distribution

  • 00813132022983 ()

  • Outer Diameter: 2.3 Millimeter
423-050

  • Atherectomy laser system beam guide-catheter, peripheral
Turbo-Tandem™ Laser Guide Catheter with Laser Atherectomy Catheter
Spectranetics Corporation
482-110AA
In Commercial Distribution

  • M204482110AA0 ()
  • 00813132020255 ()

  • Length: 110 Centimeter
482-110

  • Atherectomy laser system beam guide-catheter, peripheral
Turbo-Tandem™ Laser Guide Catheter with Laser Atherectomy Catheter
Spectranetics Corporation
472-110AA
In Commercial Distribution

  • M204472110AA0 ()
  • 00813132020231 ()

  • Length: 110 Centimeter
472-110

  • Atherectomy laser system beam guide-catheter, peripheral
Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
425-135-01AA
In Commercial Distribution

  • 00813132020217 ()
  • M20442513501AA0 ()

  • Outer Diameter: 2.6 Millimeter
425-135-01

  • Atherectomy laser system beam guide-catheter, peripheral
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