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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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DIAMONDBACK PERIPHERAL, MICRO CROWN, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-125MICRO145
In Commercial Distribution

  • 10850000491172 ()

  • Intro Sheath: 4 Fr
  • Max OD: 0.052 inches
  • Crown type: Micro
  • high speed: 140 krpm
  • medium speed: 90 krpm
  • low speed: 60 krpm
  • Guidewire: 0.014 inches
  • shaft length: 145 cm
  • nose length: 7 mm
  • Crown diameter: 1.25 mm
7-10057-01

  • Mechanical atherectomy system catheter, peripheral
Diamondback Peripheral, Exchangeable Series, Handle Only
Cardiovascular Systems, Inc.
DBP-EX-HANDLE
In Commercial Distribution

  • 10850000491035 ()
7-10032-01

  • Mechanical atherectomy system catheter, peripheral
Diamondback Peripheral, Exchangeable Series, Cartridge, 2.00 Classic, 145 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-200CLA145
In Commercial Distribution

  • 10850000491028 ()

  • Intro Sheath: 6 Fr
  • Max OD: 0.079 inches
  • Crown Type: Classic
  • High Speed: 140krpm
  • Medium Speed: 90krpm
  • Low Speed: 60krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 145cm
  • Nose Length: 20mm
  • Crown Diameter: 2.00mm
7-10031-11

  • Mechanical atherectomy system catheter, peripheral
Diamondback Peripheral, Exchangeable Series, Cartridge, 1.50 Clasic, 145 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-150CLA145
In Commercial Distribution

  • 10850000491011 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.063 inches
  • Crown Type: Classic
  • High Speed: 140krpm
  • Medium Speed: 90krpm
  • Low Speed: 60krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 145cm
  • Nose Length: 15mm
  • Crown Diameter: 1.50mm
7-10031-10

  • Mechanical atherectomy system catheter, peripheral
Diamondback Peripheral, Exchangeable Series, Cartridge, 1.75 Solid, 180 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-175SOL180
In Commercial Distribution

  • 10852528005008 ()

  • Intro Sheath: 6 Fr
  • Max OD: 0.069 inches
  • Crown Type: Solid
  • High Speed: 120krpm
  • Medium Speed: 90krpm
  • Low Speed: 60krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 180cm
  • Nose Length: 30mm
  • Crown Diameter: 1.75mm
7-10031-09

  • Mechanical atherectomy system catheter, peripheral
DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT
Cardiovascular Systems, Inc.
DBEC-125
In Commercial Distribution

  • 10850026568698 ()

  • Low Speed 80krpm
  • Medium Speed krpm
  • High Speed 120krpm
  • Crown Type Classic
  • Max OD 0.0495in
  • Intro Sheath 6Fr
  • Crown Diameter 1.25mm
  • Nose Length 5mm
  • Shaft Length: 135 Centimeter
  • Guidewire Size OD 0.012in
7-10098-01

  • Mechanical atherectomy system, coronary, line-powered
4gram tip, short taper, .014" diameter 300cm
Cardiovascular Systems, Inc.
04G-300-014
Not in Commercial Distribution

  • 10852528005626 ()
  • 30852528005620 ()

  • Max Tip Diameter: 0.014 inches; Tip Support: 4 grams; Length: 300cm
7-10049-02

  • Peripheral vascular guidewire, manual
4gram tip, short taper, .014" diameter 195cm
Cardiovascular Systems, Inc.
04G-195-014
Not in Commercial Distribution

  • 30852528005613 ()
  • 10852528005619 ()

  • Max Tip Diameter: 0.014 inches; Tip Support: 4 grams; Length: 195cm
7-10049-01

  • Peripheral vascular guidewire, manual
30gram tip, short taper, .018" diameter 300cm
Cardiovascular Systems, Inc.
30G-300-018
Not in Commercial Distribution

  • 30852528005606 ()
  • 10852528005602 ()

  • Max Tip Diameter: 0.018 inches; Tip Support: 30 grams; Length: 300cm
7-10050-08

  • Peripheral vascular guidewire, manual
30gram tip, short taper, .018" diameter 195cm
Cardiovascular Systems, Inc.
30G-195-018
Not in Commercial Distribution

  • 30852528005590 ()
  • 10852528005596 ()

  • Max Tip Diameter: 0.018 inches; Tip Support: 30 grams; Length: 195cm
7-10050-07

  • Peripheral vascular guidewire, manual
30gram tip, short taper, .014" diameter 300cm
Cardiovascular Systems, Inc.
30G-300-014
Not in Commercial Distribution

  • 30852528005583 ()
  • 10852528005589 ()

  • Max Tip Diameter: 0.014 inches; Tip Support: 30 grams; Length: 300cm
7-10050-06

  • Peripheral vascular guidewire, manual
30gram tip, short taper, .014" diameter 195cm
Cardiovascular Systems, Inc.
30G-195-014
Not in Commercial Distribution

  • 30852528005576 ()
  • 10852528005572 ()

  • Max Tip Diameter: 0.014 inches; Tip Support: 30 grams; Length: 195cm
7-10050-05

  • Peripheral vascular guidewire, manual
12gram tip, long taper, .018" diameter 300cm
Cardiovascular Systems, Inc.
12G-300-018
Not in Commercial Distribution

  • 30852528005569 ()
  • 10852528005565 ()

  • Max Tip Diameter: 0.018 inches; Tip Support: 12 grams; Length: 300cm
7-10050-04

  • Peripheral vascular guidewire, manual
12gram tip, long taper, .018" diameter 195cm
Cardiovascular Systems, Inc.
12G-195-018
Not in Commercial Distribution

  • 30852528005552 ()
  • 10852528005558 ()

  • Max Tip Diameter: 0.018 inches; Tip Support: 12 grams; Length: 195cm
7-10050-03

  • Peripheral vascular guidewire, manual
12gram tip, long taper, .014" diameter 300cm
Cardiovascular Systems, Inc.
12G-300-014
Not in Commercial Distribution

  • 30852528005545 ()
  • 10852528005541 ()

  • Max Tip Diameter: 0.014 inches; Tip Support: 12 grams; Length: 300cm
7-10050-02

  • Peripheral vascular guidewire, manual
12 gram tip, long taper, .014" diameter 195cm
Cardiovascular Systems, Inc.
12G-195-014
Not in Commercial Distribution

  • 30852528005538 ()
  • 10852528005534 ()

  • Max Tip Diameter: 0.014 inches; Tip Support: 12 grams; Length: 195cm
7-10050-01

  • Peripheral vascular guidewire, manual
6 gram tip, long taper, .018" diameter 300cm
Cardiovascular Systems, Inc.
06G-300-018
Not in Commercial Distribution

  • 30852528005521 ()
  • 10852528005527 ()

  • Max Tip Diameter: 0.018 inches; Tip Support: 6 grams; Length: 300cm
7-10049-08

  • Peripheral vascular guidewire, manual
6gram tip, long taper, .018" diameter 195cm
Cardiovascular Systems, Inc.
06G-195-018
Not in Commercial Distribution

  • 30852528005514 ()
  • 10852528005510 ()

  • Max Tip Diameter: 0.018 inches; Tip Support: 6 grams; Length: 195cm
7-10049-07

  • Peripheral vascular guidewire, manual
6gram tip, long taper, .014" diameter 300cm
Cardiovascular Systems, Inc.
06G-300-014
Not in Commercial Distribution

  • 30852528005507 ()
  • 10852528005503 ()

  • Max Tip Diameter: 0.014 inches; Tip Support: 6 grams; Length: 300cm
7-10049-06

  • Peripheral vascular guidewire, manual
6gram tip, long taper, .014" diameter 195cm
Cardiovascular Systems, Inc.
06G-195-014
Not in Commercial Distribution

  • 30852528005491 ()
  • 10852528005497 ()

  • Max Tip Diameter: 0.014 inches; Tip Support: 6 grams; Length: 195cm
7-10049-05

  • Peripheral vascular guidewire, manual
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