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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 - 10850000491295

STEALTH PERIPHERAL, SOLID CROWN, 2.00MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-200
In Commercial Distribution

  • 10850000491295 ()

  • Intro Shealth 6 Fr
  • Max OD 0.079 inches
  • Crown Type Solid
  • High Speed 120 krpm
  • Medium Speed 90 krpm
  • Low Speed 60 krpm
  • Guidewire 0.014 inches
  • Shaft Length 145 cm
  • Nose Length 30 mm
  • Crown Diameter 2.00 mm
7-10059-04

  • Mechanical atherectomy system catheter, peripheral

Stealth - 10850000491288

STEALTH PERIPHERAL, SOLID CROWN, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-150
In Commercial Distribution

  • 10850000491288 ()

  • Intro Sheath 5 Fr
  • Max OD 0.063 inches
  • Crown Type Solid
  • 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
7-10059-03

  • Mechanical atherectomy system catheter, peripheral

Stealth - 10850000491271

STEALTH PERIPHERAL, SOLID CROWN, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-125
In Commercial Distribution

  • 10850000491271 ()

  • Intro Sheath 4 Fr
  • Max OD 0.052 inches
  • Crown Type Solid
  • High Speed 120 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
7-10059-02

  • Mechanical atherectomy system catheter, peripheral

Stealth - 10850000491264

STEALTH PERIPHERAL, MICRO CROWN, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
PRD-SC30-MICRO
In Commercial Distribution

  • 10850000491264 ()

  • Crown Diameter 1.25 mm
  • High Speed 140 krpm
  • Intro Sheath 4 Fr
  • Max OD 0.052 inches
  • Crown Type Micro
  • Medium Speed 90 krpm
  • Low Speed 60 krpm
  • Guidewire 0.014 inches
  • Shaft Length 145 cm
7-10059-01

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10850000491257

DIAMONDBACK PERIPHERAL, CLASSIC CROWN, 2.00MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-200CLASS145
In Commercial Distribution

  • 10850000491257 ()

  • Intro Sheath: 6 Fr
  • Max OD: 0.079 inches
  • Crown Type: Classic
  • 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
7-10057-09

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10850000491240

DIAMONDBACK PERIPHERAL, CLASSIC CROWN, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-150CLASS145
In Commercial Distribution

  • 10850000491240 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.063 inches
  • Crown Type: Classic
  • 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
7-10057-08

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10850000491233

Diamondback Peripheral, Solid Crown, 1.75MM, 180CM shaft
Cardiovascular Systems, Inc.
DBP-175SOLID180
In Commercial Distribution

  • 10850000491233 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.069 inches
  • Crown Type: Solid
  • high speed: 120 krpm
  • medium speed: 90 krpm
  • low speed: 60 krpm
  • Guidewire: 0.014 inches
  • shaft length: 180 cm
  • nose length: 30 mm
  • Crown diameter: 1.75 mm
7-10057-07

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10850000491226

Diamondback Peripheral, Solid Crown, 1.50MM, 200CM shaft
Cardiovascular Systems, Inc.
DBP-150SOLID200
In Commercial Distribution

  • 10850000491226 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.063 inches
  • Crown Type: Solid
  • high speed: 120 krpm
  • medium speed: 90 krpm
  • low speed: 60 krpm
  • Guidewire: 0.014 inches
  • shaft length: 200 cm
  • nose length: 10 mm
  • Crown diameter: 1.50 mm
7-10057-06

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10850000491219

Diamondback Peripheral, Solid Crown, 1.25MM, 200CM shaft
Cardiovascular Systems, Inc.
DBP-125SOLID200
In Commercial Distribution

  • 10850000491219 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.063 inches
  • Crown Type: Solid
  • high speed: 120 krpm
  • medium speed: 90 krpm
  • low speed: 60 krpm
  • Guidewire: 0.014 inches
  • shaft length: 200 cm
  • nose length: 10 mm
  • Crown diameter: 1.25 mm
7-10057-05

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10850000491202

DIAMONDBACK PERIPHERAL, SOLID CROWN, 2.00MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-200SOLID145
In Commercial Distribution

  • 10850000491202 ()

  • Intro Sheath: 6 Fr
  • Max OD: 0.079 inches
  • Crown Type: Solid
  • high speed: 120 krpm
  • medium speed: 90 krpm
  • low speed: 60 krpm
  • Guidewire: 0.014 inches
  • shaft length: 145 cm
  • nose length: 30 mm
  • Crown diameter: 2.00 mm
7-10057-04

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10850000491196

DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-150SOLID145
In Commercial Distribution

  • 10850000491196 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.063 inches
  • Crown Type: Solid
  • 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
7-10057-03

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10850000491189

DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-125SOLID145
In Commercial Distribution

  • 10850000491189 ()

  • Intro Sheath: 4 Fr
  • Max OD: 0.052 inches
  • Crown Type: Solid
  • high speed: 120 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
7-10057-02

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10850000491172

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 - 10850000491035

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 - 10850000491028

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 - 10850000491011

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 - 10852528005978

Diamondback Peripheral, Exchangeable Series, Cartridge, 1.25 Solid 75 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-125SOL75
In Commercial Distribution

  • 10852528005978 ()

  • Intro Sheath: 4 Fr
  • Max OD: 0.052 inches
  • Crown Type: Solid
  • High Speed: 140krpm
  • Medium Speed: 90krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 75cm
  • Nose Length: 7mm
  • Crown diameter: 1.25mm
7-10031-06

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005909

Diamondback Peripheral, Exchangeable Series, 1.50 Classic, 145 cm shaft
Cardiovascular Systems, Inc.
DBP–EX-150CLA145
In Commercial Distribution

  • 10852528005909 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.063 inches
  • Crown Type: Classic
  • High Speed: 140 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 145 cm
  • Nose Length: 15 mm
  • Crown Diameter: 1.50 mm
7-10030-10

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005893

Diamondback Peripheral, Exchangeable Series, 1.75 Solid, 180 cm shaft
Cardiovascular Systems, Inc.
DBP-EX-175SOL180
In Commercial Distribution

  • 10852528005893 ()

  • Intro Sheath: 6 Fr
  • Max OD: 0.069 inches
  • Crown Type: Solid
  • High Speed: 120 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length:180 cm
  • Nose Length: 30 mm
  • Crown Diameter: 1.75 mm
7-10030-09

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005879

Diamondback Peripheral, Exchangeable Series, 1.25 Solid, 200 cm shaft
Cardiovascular Systems, Inc.
DBP-EX-125SOL200
In Commercial Distribution

  • 10852528005879 ()

  • Intro Sheath: 4 Fr
  • Max OD: 0.063 inches
  • Crown Type: Solid
  • High Speed: 120 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 200 cm
  • Nose Length: 10 mm
  • Crown Diameter: 1.25 mm
7-10030-07

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005855

Diamondback Peripheral, Exchangeable Series, 1.25 Micro, 75 cm shaft
Cardiovascular Systems, Inc.
DBP-EX-125MIC75
In Commercial Distribution

  • 10852528005855 ()

  • 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: 75 cm
  • Nose Length: 7 mm
  • Crown Diameter: 1.25 mm
7-10030-05

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005831

Diamondback Peripheral, Exchangeable Series, 1.50 Solid, 145 cm shaft
Cardiovascular Systems, Inc.
DBP-EX-150SOL145
In Commercial Distribution

  • 10852528005831 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.063 inches
  • Crown Type: Solid
  • High Speed: 120 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 145 cm
  • Nose Length: 10 mm
  • Crown Diameter: 1.50 mm
7-10030-03

  • Mechanical atherectomy system catheter, peripheral

Extended Length ViperWire Advance - 10852528005732

ViperWire, Advance, , Flex Tip, Extended Length, Peripheral, 0.014" Dia spring tip, 475cm, 5 Pack
Cardiovascular Systems, Inc.
VPR-GW-ELFLEX14
In Commercial Distribution

  • 30852528005736 ()
  • 10852528005732 ()

  • Max Tip Diameter 0.014 inches
7-10041-01

  • Peripheral vascular guidewire, manual

ViperWire Advance FlexTip - 10852528005718

VIPERWIRE, ADVANCE FLEXTIP PERIPHERAL, .014" DIA SPRING TIP, 335CM, 5 PACK
Cardiovascular Systems, Inc.
VPR-GW-FLEX14
In Commercial Distribution

  • 10852528005718 ()
  • 30852528005712 ()

  • Max Tip Diameter 0.014 inches
7-10041-03

  • Peripheral vascular guidewire, manual

Diamondback Coronary - 10852528005701

Guidewire, Viperwire Advance Coronary Flex Tip .014: dia, .012" 1 Pack 325 cm
Cardiovascular Systems, Inc.
GWC-12325LG-FT
In Commercial Distribution

  • 30852528005705 ()
  • 10852528005701 ()

  • Length 325 cm
  • Max Shaft Diameter 0.012 inches
  • Max Tip Diameter: 0.014 inches
7-10038-01

  • Cardiac/peripheral vascular guidewire, single-use

ViperCath XC - 10852528005688

200 cm, 0.035" guidewire compatible, support catheter
Cardiovascular Systems, Inc.
035-XC-200-0
In Commercial Distribution

  • 10852528005688 ()

  • Max Outer Diameter: 0.059 inches
  • Inner Diameter: 0.035 inches
  • Length: 200 cm
7-10043-01

  • Vascular guide-catheter, single-use

ZILIENT - 10852528005626

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

ZILIENT - 10852528005619

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

ZILIENT - 10852528005602

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

ZILIENT - 10852528005596

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

ZILIENT - 10852528005589

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

ZILIENT - 10852528005572

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

ZILIENT - 10852528005565

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

ZILIENT - 10852528005558

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

ZILIENT - 10852528005541

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

ZILIENT - 10852528005534

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

ZILIENT - 10852528005527

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

ZILIENT - 10852528005510

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

ZILIENT - 10852528005503

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

ZILIENT - 10852528005497

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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