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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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Tangible Clean is a multipurpose contact lens cleaner designed for use with gas permeable contact lenses, and is compatible for use with Tangible Hydra-PEG.
TANGIBLE SCIENCE, LLC
A
In Commercial Distribution

  • B673FG08230 ()
FG0823

  • Multi-purpose soft/rigid contact lens solution
  • Multi-purpose rigid contact lens solution
The GoPLF! Auxiliary instrument set is an optional instrument that can be used if there is a surgical need for rod reduction (system-specific instruments)
GetSet Surgical SA
4010002
In Commercial Distribution

  • 07640387660836 ()


  • Internal spinal fixation procedure kit, single-use
Tangible Clean is a multipurpose contact lens cleaner designed for use with gas permeable contact lenses, and is compatible for use with Tangible Hydra-PEG.
TANGIBLE SCIENCE, LLC
A
In Commercial Distribution

  • 00198168983577 ()
FG0823

  • Multi-purpose soft/rigid contact lens solution
  • Multi-purpose rigid contact lens solution
EDWARDS EXPANDABLE INTRODUCER SHEATH SET
Edwards Lifesciences LLC
920ES29
In Commercial Distribution

  • 00690103193466 ()

  • 20 FRENCH NOMINAL INTRODUCER SHEATH INNER DIAMETER IS COMPATIBLE WITH THE 29 MM VALVE AND DELIVERY SYSTEM
920ES29A

  • Vascular catheter introduction set, nonimplantable
EDWARDS EXPANDABLE INTRODUCER SHEATH SET
Edwards Lifesciences LLC
918ES26
In Commercial Distribution

  • 00690103192117 ()

  • 18 FRENCH NOMINAL INTRODUCER SHEATH INNER DIAMETER IS COMPATIBLE WITH THE 26 MM VALVE AND DELIVERY SYSTEM
918ES26A

  • Vascular catheter introduction set, nonimplantable
EDWARDS EXPANDABLE INTRODUCER SHEATH SET
Edwards Lifesciences LLC
916ES23
In Commercial Distribution

  • 00690103192100 ()

  • 16 FRENCH NOMINAL INTRODUCER SHEATH INNER DIAMETER IS COMPATIBLE WITH THE 23 MM VALVE AND DELIVERY SYSTEM
916ES23A

  • Vascular catheter introduction set, nonimplantable
RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter for coronary indications. RX NC TAKERU is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
DC-RZ4030UA2
In Commercial Distribution

  • 04540778170995 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Guiding Catheter; 5 Fr
  • Rated Burst Pressure; 20 atm
  • Nominal Pressure; 12 atm
  • Proximal Shaft Diameter; 2.1 Fr
  • Distal Shaft Diameter; 2.8 Fr
  • Catheter Working Length; 1450 mm
  • Balloon Length; 30 mm
  • Balloon Diameter; 4.0 mm
DC-RZ4030UA2

  • Coronary angioplasty balloon catheter, basic
RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter for coronary indications. RX NC TAKERU is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
DC-RZ3530UA2
In Commercial Distribution

  • 04540778170971 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Guiding Catheter; 5 Fr
  • Rated Burst Pressure; 20 atm
  • Nominal Pressure; 12 atm
  • Proximal Shaft Diameter; 2.1 Fr
  • Distal Shaft Diameter; 2.6 Fr
  • Catheter Working Length; 1450 mm
  • Balloon Length; 30 mm
  • Balloon Diameter; 3.5 mm
DC-RZ3530UA2

  • Coronary angioplasty balloon catheter, basic
RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter for coronary indications. RX NC TAKERU is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
DC-RZ3030UA2
In Commercial Distribution

  • 04540778170957 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Guiding Catheter; 5 Fr
  • Rated Burst Pressure; 20 atm
  • Nominal Pressure; 12 atm
  • Proximal Shaft Diameter; 2.1 Fr
  • Distal Shaft Diameter; 2.6 Fr
  • Catheter Working Length; 1450 mm
  • Balloon Length; 30 mm
  • Balloon Diameter; 3.0 mm
DC-RZ3030UA2

  • Coronary angioplasty balloon catheter, basic
RX NC TAKERU is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter for coronary indications. RX NC TAKERU is a rapid exchange (RX) type and the maximum diameter of the compatible guidewire is 0.014 inches (0.36 mm).
KANEKA CORPORATION
DC-RZ2530UA2
In Commercial Distribution

  • 04540778170933 ()

  • Maximum Guidewire Diameter; 0.014 inch
  • Compatible Guiding Catheter; 5 Fr
  • Rated Burst Pressure; 20 atm
  • Nominal Pressure; 12 atm
  • Proximal Shaft Diameter; 2.1 Fr
  • Distal Shaft Diameter; 2.6 Fr
  • Catheter Working Length; 1450 mm
  • Balloon Length; 30 mm
  • Balloon Diameter; 2.5 mm
DC-RZ2530UA2

  • Coronary angioplasty balloon catheter, basic
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