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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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AZOSTIX® is a firm, plastic strip to which is affixed an impregnated reagent area for estimating the amount of urea nitrogen in whole blood to provide information on renal function.
Siemens Healthcare Diagnostics Inc.
10324060
In Commercial Distribution

  • 00630414551142 ()
  • 00630414009544 ()
A2830C16

  • Urea IVD, kit, enzyme spectrophotometry
The PercussiveNEB 2.0 is an intrapulmonary percussive treatment device that incorporates a nebulizer which delivers aerosolized medication and is designed to oscillate during exhalation and inhalation to help remove endobronchial secretions.
VORTRAN MEDICAL TECHNOLOGY 1, INC
8030
In Commercial Distribution

  • 20637320080302 ()
  • 10637320080305 ()
8030

  • Ultrasonic nebulizing system
A long flexible tube with an inflatable balloon at its distal tip used to dilate gastrointestinal strictures of the lower esophageal schinctor. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device is multi-lumen and wire-guided. This is a single-use device.
HOBBS MEDICAL, INC.
3306
In Commercial Distribution

  • M84933060 ()
3306

  • Oesophageal balloon catheter
A long flexible tube with an inflatable balloon at its distal tip used to dilate gastrointestinal strictures of the lower esophageal schinctor. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device is multi-lumen and wire-guided. This is a single-use device.
HOBBS MEDICAL, INC.
3304
In Commercial Distribution

  • M84933040 ()
3304

  • Oesophageal balloon catheter
A long flexible tube with an inflatable balloon at its distal tip used to dilate gastrointestinal strictures of the lower esophageal schinctor. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device is multi-lumen and wire-guided. This is a single-use device.
HOBBS MEDICAL, INC.
3302
In Commercial Distribution

  • M84933020 ()
3302

  • Oesophageal balloon catheter
The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. the mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device(s), provided non-sterile, meet ASTM F2100 LEVEL 3. The Surgical Mask is single use, three-layer, flat –folded masks with ties and nose wire. This Mask is manufactured with three layers, the inner and outer layers are made of spun- bond polypropylene, and the middle layer is made of meltblown polypropylene filter. The ties welded are used to keep the mask close to the mouth and the nose. The tie is made of spunbond polypropylene. The nose wire is to allow the user to fit the facemask around their nose, which is made of polyethylene wire. The surgical masks will be provided in green and Blue. The surgical mask is sold non-sterile and are intended to be single use, disposable device.
KENPAX INTERNATIONAL LIMITED
1
In Commercial Distribution

  • 84895237109112 ()
  • 74895237109115 ()
68-8518-B

  • Surgical/medical face mask, single-use
The Integra Ti6 Internal Fixation System is comprised of Headless screws used for bone fixation of the hand and foot following trauma or osteotomy. The titanium headless screw is a cannulated dual-thread, headless bone screw which is offered in 2.5 and 3.0mm diameters with lengths of 10 to 24mm. The titanium quick snap is a snap-off solid core screw which is offered in 2.0mm and 2.7mm diameters with lengths of 8 to 22mm.The system includes titanium and stainless steel instruments to facilitate the placement of the screws.
Ascension Orthopedics, Inc.
TI6HLESSIMP
Not in Commercial Distribution

  • M268TI6HLESSIMP1 ()
  • 10381780074311 ()
TI6HLESSIMP

  • Orthopaedic bone screw, non-bioabsorbable, non-sterile
The 4mm diameter TIBIAXYS cortical screw used only on TIBIAXYS anterior plates for ankle arthrodesis (= the transarticular screw) is made from titanium alloy. It is delivered sterile and available in different sizes.
NEWDEAL
150290SND
In Commercial Distribution

  • 10381780048350 ()
  • M248150290SND1 ()

  • 4.0mm diam. x 90mm length
150290SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The 4mm diameter TIBIAXYS cortical screw used only on TIBIAXYS anterior plates for ankle arthrodesis (= the transarticular screw) is made from titanium alloy. It is delivered sterile and available in different sizes.
NEWDEAL
150285SND
In Commercial Distribution

  • 10381780048343 ()
  • M248150285SND1 ()

  • 4.0mm diam. x 85mm length
150285SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
The 4mm diameter TIBIAXYS cortical screw used only on TIBIAXYS anterior plates for ankle arthrodesis (= the transarticular screw) is made from titanium alloy. It is delivered sterile and available in different sizes.
NEWDEAL
150280SND
In Commercial Distribution

  • 10381780048336 ()
  • M248150280SND1 ()

  • 4.0mm diam. x 80mm length
150280SND

  • Orthopaedic bone screw, non-bioabsorbable, sterile
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