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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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STEALTH, SOLID, 2.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-225
In Commercial Distribution

  • 10852528005343 ()

  • 7 Fr Intro sheath
  • 0.089 inches Max OD
  • Solid Crown type
  • 120 krpm High speed
  • 90 krpm Medium speed
  • 60 krpm Low speed
  • 0.014 inches Guidewire size OD
  • 145 cm Shaft Length
  • 30 mm Nose length
  • 2.25 mm Crown diameter
70056-07

  • Mechanical atherectomy system catheter, peripheral
DIAMONDBACK PERIPHERAL, SOLID CROWN, 2.00MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP–200SOLID145
In Commercial Distribution

  • 10852528005275 ()

  • Crown Type, Solid
  • Intro Sheath 6Fr
  • Max OD 0.079 inches
  • High speed 120krpm
  • Medium speed 90krpm
  • Low speed 60krpm
  • Guidewire 0.014 inches
  • Shaft length 145cm
  • Nose length 30mm
  • Crown diameter 2.00mm
DBP–200SOLID145

  • Mechanical atherectomy system catheter, peripheral
DIAMONDBACK PERIPHERAL, MICRO CROWN, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-125MICRO145
Not in Commercial Distribution

  • 10852528005190 ()

  • Crown Type, Micro
  • Intro Sheath 4 Fr
  • Max OD 0.052 inches
  • High Speed 140 krpm
  • Medium Speed 90 krpm
  • Low Speed 60 krpm
  • Guidewire Size OD 0.014 inches
  • Shaft Length 145 cm
  • Nose Length 7 mm
  • Crown Diameter 1.25 mm
DBP-125MICRO145

  • Mechanical atherectomy system catheter, peripheral
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
VIPERTRACK, 20 PACK
Cardiovascular Systems, Inc.
VPRTRKMM20
In Commercial Distribution

  • 30852528005118 ()
  • 10852528005114 ()

  • Length: 500 Millimeter
72029-01

  • X-ray film ruler
VIPERTRACK, 50 PACK
Cardiovascular Systems, Inc.
VPR-TRK
In Commercial Distribution

  • 30852528005101 ()
  • 10852528005107 ()

  • Length: 30 Centimeter
72014-02

  • X-ray film ruler
VIPERTRACK, 20 PACK
Cardiovascular Systems, Inc.
VPR-TRK 20
In Commercial Distribution

  • 10852528005091 ()
  • 30852528005095 ()

  • Length: 30 Centimeter
72014-01

  • X-ray film ruler
VIPERWIRE, ADVANCE PERIPHERAL, .017" DIA SPRING TIP, 335CM, 5 PACK
Cardiovascular Systems, Inc.
VPR-GW-17
In Commercial Distribution

  • 30852528005088 ()
  • 10852528005084 ()

  • Length: 335 Centimeter
  • Shaft Diameter 0.014 inches
  • Max Tip Diameter 0.017 inches
72023-02

  • Peripheral vascular guidewire, manual
VIPERWIRE, ADVANCE PERIPHERAL, .014" DIA SPRING TIP, 335CM, 5 PACK
Cardiovascular Systems, Inc.
VPR-GW-14
In Commercial Distribution

  • 30852528005071 ()
  • 10852528005077 ()

  • Length: 335 Centimeter
  • Shaft Diameter 0.014 inches
  • Max Tip Diameter 0.014 inches
72023-01

  • Peripheral vascular guidewire, manual
STEALTH, SOLID MICRO, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-125S
In Commercial Distribution

  • 10852528005060 ()

  • Crown Type, Solid Micro
  • Intro Sheath 6Fr
  • Max OD 0.070 inches
  • high speed 120 krpm
  • medium speed 90 krpm
  • low speed 60 krpm
  • guidewire OD 0.014 inches
  • shaft length 145 cm
  • nose length 10 mm
  • Crown Diameter 1.25 mm
70056-11

  • Mechanical atherectomy system catheter, peripheral
STEALTH, SOLID, 2.00MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-200
In Commercial Distribution

  • 10852528005053 ()

  • Intro Sheath 6 Fr
  • Max OD 0.079 inches
  • high speed 120 krpm
  • medium speed 90 krpm
  • low speed 60 krpm
  • guidewire size OD 0.014 inches
  • shaft length 145 cm
  • Nose Length 30 mm
  • Crown Diameter 2.00 mm
  • Crown Type, Solid
70056-06

  • Mechanical atherectomy system catheter, peripheral
STEALTH, SOLID, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-150
In Commercial Distribution

  • 10852528005046 ()

  • Intro Sheath 6 Fr
  • max OD 0.070 inches
  • high speed 120 krpm
  • medium speed 90 krpm
  • low speed 60 krpm
  • guidewire size OD 0.014 inches
  • shaft length 145 cm
  • nose length 10 mm
  • Crown diameter 1.50 mm
  • Crown Type, Solid
70056-04

  • Mechanical atherectomy system catheter, peripheral
STEALTH, SOLID, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-125
In Commercial Distribution

  • 10852528005039 ()

  • Intro Sheath 6 Fr
  • Max OD 0.070 inches
  • high speed 120 krpm
  • medium speed 90 krpm
  • low speed 60 krpm
  • guidewire size OD 0.014 inches
  • shaft length 145 cm
  • Nose Length 10 mm
  • Crown Diameter 1.25 mm
  • Crown Type, Solid
70056-03

  • Mechanical atherectomy system catheter, peripheral
STEALTH, CLASSIC, 2.00MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBE-200
In Commercial Distribution

  • 10852528005022 ()

  • Intro Sheath 6 Fr
  • Max OD 0.079 inches
  • high speed 140 krpm
  • medium speed 90 krpm
  • low speed 60 krpm
  • guidewire size OD 0.014 inches
  • shaft length 145 cm
  • nose length 20 mm
  • Crown Diameter 2.00 mm
  • Crown Type, Classic
70056-02

  • Mechanical atherectomy system catheter, peripheral
STEALTH, CLASSIC, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBE-150
In Commercial Distribution

  • 10852528005015 ()

  • Intro Sheath 6 Fr
  • Max OD 0.070 inches
  • high speed 140 krpm
  • medium speed 90 krpm
  • low speed 60 krpm
  • guidewire size OD 0.014 inches
  • shaft length 145 cm
  • nose length 15 mm
  • Crown diameter 1.50 mm
  • Crown Type, Classic
70056-01

  • Mechanical atherectomy system catheter, peripheral
No Description
Shangrao Zhuofan intelligent technology Co., LTD
ZF-M607
In Commercial Distribution

  • 06977160620055 ()


  • Air-conduction hearing aid, in-the-ear
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