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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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Paclitaxel-Coated PTA Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H74939419401290
In Commercial Distribution

  • 08714729975854 ()

  • Balloon Diameter: 4.0 Millimeter
  • Balloon Length: 120 Millimeter
  • Catheter Length: 90 Centimeter


  • Peripheral angioplasty balloon catheter, drug-coated
Paclitaxel-Coated PTA Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H74939419400410
In Commercial Distribution

  • 08714729975762 ()

  • Balloon Diameter: 4.0 Millimeter
  • Balloon Length: 40 Millimeter
  • Catheter Length: 135 Centimeter


  • Peripheral angioplasty balloon catheter, drug-coated
Paclitaxel-Coated PTA Balloon Catheter
BOSTON SCIENTIFIC CORPORATION
H74939419400310
In Commercial Distribution

  • 08714729975748 ()

  • Balloon Diameter: 4.0 Millimeter
  • Catheter Length: 135 Centimeter
  • Balloon Length: 30 Millimeter


  • Peripheral angioplasty balloon catheter, drug-coated
The SCINUS consists of a cabinet that encloses a temperature-controlled environment where a Single Use Bag can be mounted on a mixing Rocker. At the front of the cabinet, the transparent door allows access to the internal area. When opening the transparent front door, the motor of the Rocker will be switched off. In this way, a hazardous situation is prevented. At the left side of the SCINUS front panel, the Emergency Stop button is located, together with the Illumination button and the Control Panel (touch screen display that is used as Graphical User Interface). On the top of the SCINUS, four mounting positions are available for insertion of lifting lugs. The mounting positions are covered and lifting lugs are not provided with the system.
Scinus Cell Expansion Netherlands B.V.
VCL3123001
In Commercial Distribution

  • 08720299213609 ()


  • Cell culture bioreactor
The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a gastrointestinal endoscope. It provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the gastrointestinal endoscopic procedure.
US Endoscopy
00711129
Not in Commercial Distribution

  • 20816765013407 ()
  • 10816765013400 ()
  • 00816765013403 ()
00711129

  • Endoscope working-channel valve, single-use
The BioShield biopsy valve is used to cover the opening to the biopsy/suction channel inlet of a gastrointestinal endoscope. It provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the gastrointestinal endoscopic procedure.
US Endoscopy
00711125
Not in Commercial Distribution

  • 20816765013391 ()
  • 10816765013394 ()
  • 00816765013397 ()
00711125

  • Endoscope working-channel valve, single-use
The BioShield irrigating adaptor is used for intraprocedural gastrointestinal endoscopic irrigation when attached to a luer-lock or slip-tip syringe through the BioShield biopsy valve.
US Endoscopy
00711131
Not in Commercial Distribution

  • 10816765011093 ()
  • 00816765011096 ()

  • Length: 1 Inch
  • Needle Gauge: 15 Gauge
00711131

  • Endoscope working-channel valve, single-use
Biopsy Valve
ENDOCHOICE, INC.
SBC-580
Not in Commercial Distribution

  • 10840253110067 ()
  • 00840253110060 ()


  • Endoscope working-channel valve, single-use
Bronchoscope Adapter for se with Fujinon bronchoscopes
Covidien LP
ILS-2300-PK
In Commercial Distribution

  • 10884521723993 ()
  • 20884521723990 ()


  • Endoscope working-channel valve, single-use
Bronchoscope Adapter for use with Pentax bronchoscopes
Covidien LP
ILS-2200-PK
In Commercial Distribution

  • 10884521723986 ()
  • 20884521723983 ()


  • Endoscope working-channel valve, single-use
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