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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IdentiTi ALIF SA Center Screw, Ø6 x 30 mm
ALPHATEC SPINE, INC.
232-12-60-300
In Commercial Distribution

  • 00190376370477 ()

  • Outer Diameter: 6 Millimeter
  • Length: 30 Millimeter


  • Metallic spinal interbody fusion cage
The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary tree. The Niti-S Biliary Stent consists of an implantable metallic stent and a disposable, flexible introducer system for placement of the stent. The stent is a flexible and expandable tubular device made of Nitinol wire that is intended to be implanted to restore the structure and/or function of the biliary system. The introducer is a disposable system for delivery and deployment of the stent at the target position. Upon deployment, the stent imparts an outward radial force on the luminal surface of the biliary system to establish and maintain patency. The stent is available in two diameters (8, 10mm), and eight lengths (40, 50, 60, 70, 80, 90, 100, 120mm). The stent has 10 radiopaque markers. There are two different types of introducers; percutaneous or endoscopic. They consists of an Inner Catheter, Outer Sheath, Hub, Y-connector, Tip and Pusher. All of the components of the introducers are supplied sterile in a disposable package. The Percutaneous type introducer is used when the site is accessed percutaneously and requires a guidewire (not included) to be advanced across the targeted stricture under fluoroscopy. The Endoscopic type introducer is for use in endoscopic procedures where the stent and introducer are inserted through the channel of an endoscope. The usable lengths of Percutaneous type introducer is 50cm and Endoscopic type introducer 180cm. Other information: The package is sterilized using Ethylene oxide. The diameter of compatible guide wire is 0.035 inch (0.89mm). Do not use if package is damaged. Do not reuse or resterilize.
TAEWOONGMEDICAL.CO.,LTD
BD0812
In Commercial Distribution

  • 08809233102008 ()

  • Length: 120 Millimeter
  • Outer Diameter: 8 Millimeter
  • Catheter Gauge: 8 French
  • Catheter Usable Length: 180cm
BD0812

  • Bare-metal biliary stent
The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary tree. The Niti-S Biliary Stent consists of an implantable metallic stent and a disposable, flexible introducer system for placement of the stent. The stent is a flexible and expandable tubular device made of Nitinol wire that is intended to be implanted to restore the structure and/or function of the biliary system. The introducer is a disposable system for delivery and deployment of the stent at the target position. Upon deployment, the stent imparts an outward radial force on the luminal surface of the biliary system to establish and maintain patency. The stent is available in two diameters (8, 10mm), and eight lengths (40, 50, 60, 70, 80, 90, 100, 120mm). The stent has 10 radiopaque markers. There are two different types of introducers; percutaneous or endoscopic. They consists of an Inner Catheter, Outer Sheath, Hub, Y-connector, Tip and Pusher. All of the components of the introducers are supplied sterile in a disposable package. The Percutaneous type introducer is used when the site is accessed percutaneously and requires a guidewire (not included) to be advanced across the targeted stricture under fluoroscopy. The Endoscopic type introducer is for use in endoscopic procedures where the stent and introducer are inserted through the channel of an endoscope. The usable lengths of Percutaneous type introducer is 50cm and Endoscopic type introducer 180cm. Other information: The package is sterilized using Ethylene oxide. The diameter of compatible guide wire is 0.035 inch (0.89mm). Do not use if package is damaged. Do not reuse or resterilize.
TAEWOONGMEDICAL.CO.,LTD
TD1012
In Commercial Distribution

  • 08809233100615 ()

  • Length: 120 Millimeter
  • Outer Diameter: 10 Millimeter
  • Catheter Gauge: 8 French
  • Catheter Usable Length: 50cm
TD1012

  • Bare-metal biliary stent
The Niti-S Biliary Stent is indicated for the palliation of malignant strictures in the biliary tree. The Niti-S Biliary Stent consists of an implantable metallic stent and a disposable, flexible introducer system for placement of the stent. The stent is a flexible and expandable tubular device made of Nitinol wire that is intended to be implanted to restore the structure and/or function of the biliary system. The introducer is a disposable system for delivery and deployment of the stent at the target position. Upon deployment, the stent imparts an outward radial force on the luminal surface of the biliary system to establish and maintain patency. The stent is available in two diameters (8, 10mm), and eight lengths (40, 50, 60, 70, 80, 90, 100, 120mm). The stent has 10 radiopaque markers. There are two different types of introducers; percutaneous or endoscopic. They consists of an Inner Catheter, Outer Sheath, Hub, Y-connector, Tip and Pusher. All of the components of the introducers are supplied sterile in a disposable package. The Percutaneous type introducer is used when the site is accessed percutaneously and requires a guidewire (not included) to be advanced across the targeted stricture under fluoroscopy. The Endoscopic type introducer is for use in endoscopic procedures where the stent and introducer are inserted through the channel of an endoscope. The usable lengths of Percutaneous type introducer is 50cm and Endoscopic type introducer 180cm. Other information: The package is sterilized using Ethylene oxide. The diameter of compatible guide wire is 0.035 inch (0.89mm). Do not use if package is damaged. Do not reuse or resterilize.
TAEWOONGMEDICAL.CO.,LTD
TD0812
In Commercial Distribution

  • 08809233100509 ()

  • Length: 120 Millimeter
  • Outer Diameter: 8 Millimeter
  • Catheter Gauge: 8 French
  • Catheter Usable Length: 50cm
TD0812

  • Bare-metal biliary stent
Accessories, Implant, Dental, Endosseous
Dentium Co., Ltd.
XTP5406
In Commercial Distribution

  • 08809162705813 ()

  • Length: 37 Millimeter
  • Outer Diameter: 6 Millimeter
XTP5406

  • Fixture/appliance dental drill bit, reusable
Endosseous dental implant
Dentium Co., Ltd.
FX6008SW
In Commercial Distribution

  • 08809162700214 ()

  • Length: 8 Millimeter
  • Outer Diameter: 6 Millimeter
FX6008SW

  • Screw endosteal dental implant, two-piece
Cannulated Cortical-Cancellous Modular Screw Shank 12.5mm X 120mm
ALPHATEC SPINE, INC.
15703-125-120
In Commercial Distribution

  • 00190376328010 ()

  • Outer Diameter: 12.5 Millimeter
  • Length: 120 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Cortical-Cancellous Modular Screw Shank 12.0mm X 120mm
ALPHATEC SPINE, INC.
15703-120-120
In Commercial Distribution

  • 00190376327808 ()

  • Outer Diameter: 12 Millimeter
  • Length: 120 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Cortical-Cancellous Modular Screw Shank 11.5mm X 120mm
ALPHATEC SPINE, INC.
15703-115-120
In Commercial Distribution

  • 00190376327594 ()

  • Outer Diameter: 11.5 Millimeter
  • Length: 120 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Cannulated Cortical-Cancellous Modular Screw Shank 11.0mm X 120mm
ALPHATEC SPINE, INC.
15703-110-120
In Commercial Distribution

  • 00190376327389 ()

  • Outer Diameter: 11 Millimeter
  • Length: 120 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
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