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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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A sterile device designed to facilitate/regulate the delivery of cardioplegic solution to the heart during a cardiopulmonary bypass procedure by connecting an administration line to a cardioplegia cannula. Also known as a cardioplegia delivery set, it basically consists of tubing [e.g., polyvinyl chloride (PVC)] with connectors. It may have a single lumen or branched multiple-lumen design and include various types of connectors, clamps, and valves, depending on additional intended uses (e.g., venting, recirculation, and/or simultaneous perfusion of vein grafts). This is a single-use device.
NOVOSCI CORP.
301021-000
In Commercial Distribution

  • B0663010210006 ()
  • B0663010210000 ()
  • B0663010210005 ()
  • B0663010210004 ()
  • B0663010210003 ()
301021-000

  • Cardioplegia solution administration adaptor
A sterile, semi-rigid tube used in open heart surgery to facilitate the transfer of priming fluids during the priming of the extracorporeal circuit of a cardiopulmonary bypass system. It is a noninvasive product in the form of a tube or tubing used to channel the fluids (i.e., primer/blood) to facilitate priming of the extracorporeal circuit and connection of the cardiopulmonary bypass system (heart/lung machine) to the patient. It is typically a moulded plastic tube with hard plastic spike at the distal end that connects to the bag or container of primer solution, a connector at the proximal end, and a central pinch clamp. This is a single-use device.
NOVOSCI CORP.
301012NS
In Commercial Distribution

  • B066301012NS1 ()
  • B66301012NS0 ()
301012NS

  • Cardiopulmonary bypass system priming set
A sterile, semi-rigid tube used in open heart surgery to facilitate the transfer of priming fluids during the priming of the extracorporeal circuit of a cardiopulmonary bypass system. It is a noninvasive product in the form of a tube or tubing used to channel the fluids (i.e., primer/blood) to facilitate priming of the extracorporeal circuit and connection of the cardiopulmonary bypass system (heart/lung machine) to the patient. It is typically a moulded plastic tube with hard plastic spike at the distal end that connects to the bag or container of primer solution, a connector at the proximal end, and a central pinch clamp. This is a single-use device.
NOVOSCI CORP.
301012-000
In Commercial Distribution

  • B0663010120007 ()
  • B0663010120000 ()
  • B0663010120006 ()
  • B0663010120005 ()
  • B0663010120003 ()
301012-000

  • Cardiopulmonary bypass system priming set
A sterile, semi-rigid tube used in open heart surgery to facilitate the transfer of priming fluids during the priming of the extracorporeal circuit of a cardiopulmonary bypass system. It is a noninvasive product in the form of a tube or tubing used to channel the fluids (i.e., primer/blood) to facilitate priming of the extracorporeal circuit and connection of the cardiopulmonary bypass system (heart/lung machine) to the patient. It is typically a moulded plastic tube with hard plastic spike at the distal end that connects to the bag or container of primer solution, a connector at the proximal end, and a central pinch clamp. This is a single-use device.
NOVOSCI CORP.
301011NS
In Commercial Distribution

  • B066301011NS3 ()
  • B066301011NS1 ()
  • B066301011NS0 ()
301011NS

  • Cardiopulmonary bypass system priming set
A sterile, semi-rigid tube used in open heart surgery to facilitate the transfer of priming fluids during the priming of the extracorporeal circuit of a cardiopulmonary bypass system. It is a noninvasive product in the form of a tube or tubing used to channel the fluids (i.e., primer/blood) to facilitate priming of the extracorporeal circuit and connection of the cardiopulmonary bypass system (heart/lung machine) to the patient. It is typically a moulded plastic tube with hard plastic spike at the distal end that connects to the bag or container of primer solution, a connector at the proximal end, and a central pinch clamp. This is a single-use device.
NOVOSCI CORP.
301011-000
In Commercial Distribution

  • B0663010110000 ()
  • B0663010110003 ()
  • B0663010110005 ()
  • B0663010110007 ()
  • B0663010110006 ()
301011-000

  • Cardiopulmonary bypass system priming set
osteo-WEDGE 3.0mm x 26mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Gramedica
GM-500-26
In Commercial Distribution

  • M621OW30LBS26MM0 ()

  • 3.0mm x 26mm
OW3.0LBS-26MM

  • Orthopaedic fixation plate, non-bioabsorbable
osteo-WEDGE 3.0mm x 24mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Gramedica
GM-500-24
In Commercial Distribution

  • M621OW30LBS24MM0 ()

  • 3.0mm x 24mm
OW3.0LBS-24MM

  • Orthopaedic fixation plate, non-bioabsorbable
osteo-WEDGE 3.0mm x 22mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Gramedica
GM-500-22
In Commercial Distribution

  • M621OW30LBS22MM0 ()

  • 3.0mm x 22mm
OW3.0LBS-22MM

  • Orthopaedic fixation plate, non-bioabsorbable
osteo-WEDGE 3.0mm x 20mm Locking Bone Screw. For use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Gramedica
GM-500-20
In Commercial Distribution

  • M621OW30LBS20MM0 ()

  • 3.0mm x 20mm
OW3.0LBS-20MM

  • Orthopaedic fixation plate, non-bioabsorbable
osteo-WEDGE 3.0mm x 18mm Locking Bone Screw. Non-sterile single use implant for use with the osteo-WEDGE Opening Wedge Bone Locking Plate System. The osteo-WEDGE Opening Wedge Bone Locking Plate System is used for adult and transitional adolescent (18 to 21 years old) patients for the purpose of stabilization and/or correction of angular deviations within an individual bone or in between two adjacent bones in the foot, such as opening wedge osteotomy for first metatarsal cuneiform joint deviations.
Gramedica
GM-500-18
In Commercial Distribution

  • M621OW30LBS18MM0 ()

  • 3.0mm x 18mm
OW3.0LBS-18MM

  • Orthopaedic fixation plate, non-bioabsorbable
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