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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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BULKAMID ® - 04250480108581

Cystoscope 2.7 mm x 113 mm, 0°, Factory Exchange
SCHÖLLY FIBEROPTIC GmbH
41-0152a-FX
In Commercial Distribution

  • 04250480108581 ()

  • Direction of view 0 Degree
  • Working length 113 mm
  • Insertion tube outer diameter 2.7 mm


  • Rigid optical cystoscope

Surgical Direct - B382SD10142090

5.5mm 20cm Threaded Shaft for Exchange, 20cm Working Length
Surgical Direct, Inc.
SD1014209
In Commercial Distribution

  • B382SD10142090 ()

  • Length: 20 Centimeter
  • Outer Diameter: 5.5 Millimeter
SD1014209

  • Endoscope sheath, reusable

LMA AIRWAY MANAGEMENT - 05060112310430

LMA Fastrach™ Stabiliser Rod
TELEFLEX INCORPORATED
IPN901829
In Commercial Distribution

  • 15060112310437 ()
  • 05060112310430 ()
  • 25060112310434 ()
130099

  • Endotracheal tube stabilization rod

LMA AIRWAY MANAGEMENT - 25060112314739

LMA Fastrach™ Stabiliser Rod
TELEFLEX INCORPORATED
IPN915395
In Commercial Distribution

  • 45060112314733 ()
  • 35060112314736 ()
  • 25060112314739 ()
  • 15060112314732 ()
130099

  • Endotracheal tube stabilization rod

NA - 04055207010679

STERILE ADAPTER Plug-eyepiece for endoscope exchange under sterile conditions, lock mechanism
Richard Wolf GmbH
858091
Not in Commercial Distribution

  • 04055207010679 ()

  • Length: 40 Millimeter
8580.91

  • Endoscope camera adaptor

EndoMask Elite® - 10182151000690

Size #1, 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 #1 - 280010
In Commercial Distribution

  • 00182151000693 ()
  • 10182151000690 ()
280010

  • Oropharyngeal airway, reusable

EndoMask Elite® - 00182151000686

Size #1.5, 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 #1.5 - 280015
In Commercial Distribution

  • 10182151000683 ()
  • 00182151000686 ()
280015

  • Oropharyngeal airway, reusable

EndoMask Elite® - 00182151000679

Size #2, 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 #2 - 280020
In Commercial Distribution

  • 00182151000679 ()
  • 10182151000676 ()
280020

  • Oropharyngeal airway, reusable

EndoMask Elite® - 00182151000662

Size #2.5, 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 #2.5 - 280025
In Commercial Distribution

  • 10182151000669 ()
  • 00182151000662 ()
280025

  • Oropharyngeal airway, reusable

EndoMask Elite® - 00182151000655

Size #3, 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 #3 - 280030
In Commercial Distribution

  • 10182151000652 ()
  • 00182151000655 ()
280030

  • Oropharyngeal airway, reusable
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