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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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SALINE INFUSION PUMP (SIP)
Cardiovascular Systems, Inc.
SIP-3000
In Commercial Distribution

  • 10852528005800 ()
7-10037-07

  • Atherectomy system saline/lubricant pump
Guidewire, Viperwire Adavnce Coronary Floppy, .012: dia, .014" Spring Tip, 1 Pack 325 cm
Cardiovascular Systems, Inc.
GWC-12325LG-FLP
In Commercial Distribution

  • 30852528005187 ()
  • 10852528005183 ()

  • Length; 325cm
  • Max Shaft Diameter; 0.012 inches
  • Max Tip Diameter; 0.014 inches
72010-01

  • Cardiac/peripheral vascular guidewire, single-use
CORONARY ELECTRIC, CLASSIC CROWN, 1.50MM
Cardiovascular Systems, Inc.
DBEC-150
In Commercial Distribution

  • 10852528005176 ()

  • Intro Sheath; 6Fr
  • Max OD; 0.061 inches
  • High speed; 120krpm
  • Low speed; 80krpm
  • Guidewire size OD; 0.012 inches
  • Shaft length; 135cm
  • Nose length; 10mm
  • Crown diameter; 1.5mm
  • Crown Type, Classic
70058-03

  • Mechanical atherectomy system, coronary, line-powered
DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM
Cardiovascular Systems, Inc.
DBEC-125
In Commercial Distribution

  • 10852528005169 ()

  • Intro Sheath; 6 french
  • Max OD; 0.057 inches
  • High speed; 120 krpm
  • low speed; 80 krpm
  • Guidewire size OD; 0.012 inches
  • Shaft Length; 135 cm
  • Nose Length; 5mm
  • Crown Size; 1.25 mm
  • Crown Type, Classic
70058-02

  • Mechanical atherectomy system, coronary, line-powered
SALINE INFUSION PUMP (SIP)
Cardiovascular Systems, Inc.
SIP-3000
In Commercial Distribution

  • 10852528005138 ()
70057-03

  • Atherectomy system saline/lubricant pump
VIPERSLIDE, 100ML BAG, 10 PK
Cardiovascular Systems, Inc.
VPR-SLD2
In Commercial Distribution

  • 30852528005125 ()
  • 10852528005121 ()
72031-01

  • Atherectomy system lubricant
5
Advanced Bionics, LLC
CI-7525-005
In Commercial Distribution



  • Hearing implant system external magnet, reusable
5
Advanced Bionics, LLC
CI-7524-005
In Commercial Distribution



  • Hearing implant system external magnet, reusable
5
Advanced Bionics, LLC
CI-7524-005
In Commercial Distribution

  • 00840094499911 ()


  • Hearing implant system external magnet, reusable
5"
Advanced Bionics, LLC
CI-7405-010
In Commercial Distribution


  • Length: 13 Centimeter


  • Electrical-only medical device connection cable, reusable
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