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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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MAINSTAY MEDICAL LIMITED
EXT1
In Commercial Distribution

  • 05391527772804 ()


  • Orthopaedic inorganic implant inserter/extractor, single-use
Torque Wrench (packaged as a standalone accessory)
MAINSTAY MEDICAL LIMITED
7M5500-002
In Commercial Distribution

  • 05391527770817 ()
5500

  • Surgical torque wrench, reusable
Trapper™ Exchange Device
CREGANNA UNLIMITED COMPANY
H74939330130
In Commercial Distribution

  • 05391526210154 ()

  • Trapper is designed for use with guide catheters having internal lumen diameters in the range of 6F to 8F
  • Lumen OD: 2.0F (≤0.66mm)
  • Balloon length: 10mm
  • Working length: 97-112cm
H74939330130

  • Coronary angioplasty balloon catheter, basic
The Boss Crossing Support Catheter (Boss CSC) is intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or other diagnostic contrast agents. The device is intended for single use and is provided sterile using Ethylene Oxide gas. The device consists of two low profile catheters, 2.4F and 3.9F, which are compatible with 0.018” and 0.035” guidewires, respectively. The proximal end of each catheter includes a standard catheter hub with Luer fitting and a strain relief. The distal end of both catheters are equipped with a single marker band which enables visibility under fluoroscopy. There is a hydrophilic coating on the distal portion of each catheter shaft to enhance lubricity. The device is provided either as a kit containing one of each size catheter, or as a single pack containing only one catheter. Each catheter is packaged in individual spiral HDPE hoops that are secured to a HDPE card and placed inside a Tyvek Mylar pouch. This model is a 2.4F/135cm length catheter packaged individually.
MARVAO MEDICAL DEVICES LIMITED
180000135
In Commercial Distribution

  • 05391525640952 ()


  • Angiographic catheter, single-use
The Boss Crossing Support Catheter (Boss CSC) is intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or other diagnostic contrast agents. The device is intended for single use and is provided sterile using Ethylene Oxide gas. The device consists of two low profile catheters, 2.4F and 3.9F, which are compatible with 0.018” and 0.035” guidewires, respectively. The proximal end of each catheter includes a standard catheter hub with Luer fitting and a strain relief. The distal end of both catheters are equipped with a single marker band which enables visibility under fluoroscopy. There is a hydrophilic coating on the distal portion of each catheter shaft to enhance lubricity. The device is provided either as a kit containing one of each size catheter, or as a single pack containing only one catheter. Each catheter is packaged in individual spiral HDPE hoops that are secured to a HDPE card and placed inside a Tyvek Mylar pouch. This model is a 2.4F/135cm length catheter packaged individually.
MARVAO MEDICAL DEVICES LIMITED
180000135
In Commercial Distribution

  • 05391525640914 ()


  • Angiographic catheter, single-use
The Boss Crossing Support Catheter (Boss CSC) is intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or other diagnostic contrast agents. The device is intended for single use and is provided sterile using Ethylene Oxide gas. The device consists of two low profile catheters, 2.4F and 3.9F, which are compatible with 0.018” and 0.035” guidewires, respectively. The proximal end of each catheter includes a standard catheter hub with Luer fitting and a strain relief. The distal end of both catheters are equipped with a single marker band which enables visibility under fluoroscopy. There is a hydrophilic coating on the distal portion of each catheter shaft to enhance lubricity. The device is provided either as a kit containing one of each size catheter, or as a single pack containing only one catheter. Each catheter is packaged in individual spiral HDPE hoops that are secured to a HDPE card and placed inside a Tyvek Mylar pouch. This model is a 2.4F/90cm length catheter packaged individually
MARVAO MEDICAL DEVICES LIMITED
180000090
In Commercial Distribution

  • 05391525640853 ()


  • Angiographic catheter, single-use
The Boss Crossing Support Catheter (Boss CSC) is intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or other diagnostic contrast agents. The device is intended for single use and is provided sterile using Ethylene Oxide gas. The device consists of two low profile catheters, 2.4F and 3.9F, which are compatible with 0.018” and 0.035” guidewires, respectively. The proximal end of each catheter includes a standard catheter hub with Luer fitting and a strain relief. The distal end of both catheters are equipped with a single marker band which enables visibility under fluoroscopy. There is a hydrophilic coating on the distal portion of each catheter shaft to enhance lubricity. The device is provided either as a kit containing one of each size catheter, or as a single pack containing only one catheter. Each catheter is packaged in individual spiral HDPE hoops that are secured to a HDPE card and placed inside a Tyvek Mylar pouch. This model is a 2.4F/90cm length catheter packaged individually
MARVAO MEDICAL DEVICES LIMITED
180000090
In Commercial Distribution

  • 05391525640815 ()
180000090

  • Angiographic catheter, single-use
The Boss Crossing Support Catheter (Boss CSC) is intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or other diagnostic contrast agents. The device is intended for single use and is provided sterile using Ethylene Oxide gas. The device consists of two low profile catheters, 2.4F and 3.9F, which are compatible with 0.018” and 0.035” guidewires, respectively. The proximal end of each catheter includes a standard catheter hub with Luer fitting and a strain relief. The distal end of both catheters are equipped with a single marker band which enables visibility under fluoroscopy. There is a hydrophilic coating on the distal portion of each catheter shaft to enhance lubricity. The device is provided either as a kit containing one of each size catheter, or as a single pack containing only one catheter. Each catheter is packaged in individual spiral HDPE hoops that are secured to a HDPE card and placed inside a Tyvek Mylar pouch. This model is 3.9F/90cm length catheter packaged individually
MARVAO MEDICAL DEVICES LIMITED
350000090
In Commercial Distribution

  • 05391525640754 ()


  • Angiographic catheter, single-use
The Boss Crossing Support Catheter (Boss CSC) is intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or other diagnostic contrast agents. The device is intended for single use and is provided sterile using Ethylene Oxide gas. The device consists of two low profile catheters, 2.4F and 3.9F, which are compatible with 0.018” and 0.035” guidewires, respectively. The proximal end of each catheter includes a standard catheter hub with Luer fitting and a strain relief. The distal end of both catheters are equipped with a single marker band which enables visibility under fluoroscopy. There is a hydrophilic coating on the distal portion of each catheter shaft to enhance lubricity. The device is provided either as a kit containing one of each size catheter, or as a single pack containing only one catheter. Each catheter is packaged in individual spiral HDPE hoops that are secured to a HDPE card and placed inside a Tyvek Mylar pouch. This model is a 3.9F/90cm length catheter packaged individually
MARVAO MEDICAL DEVICES LIMITED
350000090
In Commercial Distribution

  • 05391525640716 ()


  • Angiographic catheter, single-use
The Boss Crossing Support Catheter (Boss CSC) is intended to guide and support a guidewire during access of the peripheral vasculature, allow for wire exchanges and provide a conduit for the delivery of saline or other diagnostic contrast agents. The device is intended for single use and is provided sterile using Ethylene Oxide gas. The device consists of two low profile catheters, 2.4F and 3.9F, which are compatible with 0.018” and 0.035” guidewires, respectively. The proximal end of each catheter includes a standard catheter hub with Luer fitting and a strain relief. The distal end of both catheters are equipped with a single marker band which enables visibility under fluoroscopy. There is a hydrophilic coating on the distal portion of each catheter shaft to enhance lubricity. The device is provided either as a kit containing one of each size catheter, or as a single pack containing only one catheter. Each catheter is packaged in individual spiral HDPE hoops that are secured to a HDPE card and placed inside a Tyvek Mylar pouch. This model is a 3.9F/90cm length catheter packaged with a 2.4F /150cm length catheter.
MARVAO MEDICAL DEVICES LIMITED
359018150
In Commercial Distribution

  • 05391525640617 ()
359018150

  • Angiographic catheter, single-use
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