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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 - 10852528005763

Stealth, Radial Access OAD, 1.50mm, 10mm, 200cm shaft
Cardiovascular Systems, Inc.
RAD-SC30-150
In Commercial Distribution

  • 10852528005763 ()

  • Crown Diameter 1.5 mm
7-10058-02

  • Mechanical atherectomy system catheter, peripheral

Stealth - 10852528005756

Stealth, Radial Access OAD, 1.25mm, 10mm, 200cm shaft
Cardiovascular Systems, Inc.
RAD-SC30-125
In Commercial Distribution

  • 10852528005756 ()

  • Crown diameter 1.25mm
7-10058-01

  • Mechanical atherectomy system catheter, peripheral

Extended Length ViperWire Advance - 10852528005749

ViperWire, Advance, Flex Tip, Extended Length, Peripheral, 0.018" Dia spring tip, 475cm, 5 Pack
Cardiovascular Systems, Inc.
VPR-GW-ELFLEX18
In Commercial Distribution

  • 30852528005743 ()
  • 10852528005749 ()

  • Max Tip Diameter 0.018 inches
7-10041-02

  • Peripheral vascular guidewire, manual

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 - 10852528005725

VIPERWIRE, ADVANCE FLEXTIP PERIPHERAL, .018" DIA SPRING TIP, 335CM, 5 PACK
Cardiovascular Systems, Inc.
VPR-GW-FLEX18
In Commercial Distribution

  • 30852528005729 ()
  • 10852528005725 ()

  • Max Tip Diameter 0.018 inches
7-10041-04

  • 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 - 10852528005695

200 cm, 0.035" guidewire compatible, support catheter
Cardiovascular Systems, Inc.
035-XC-200-1
In Commercial Distribution

  • 10852528005695 ()

  • Max Outer Diameter: 0.059 inches
  • Inner Diameter: 0.035 inches
  • Length: 200 cm
7-10043-02

  • Vascular guide-catheter, 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

ZILIENT - 10852528005480

4gram tip, short taper, .018" diameter 300cm
Cardiovascular Systems, Inc.
04G-300-018
Not in Commercial Distribution

  • 30852528005484 ()
  • 10852528005480 ()

  • Max Tip Diameter: 0.018 inches; Tip Support: 4 grams; Length: 300cm
7-10049-04

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005473

4gram tip, short taper, .018" diameter 195cm
Cardiovascular Systems, Inc.
04G-195-018
Not in Commercial Distribution

  • 10852528005473 ()
  • 30852528005477 ()

  • Max Tip Diameter: 0.018 inches; Tip Support: 4 grams; Length: 195cm
7-10049-03

  • Peripheral vascular guidewire, manual

Extended Length ViperWire Advance - 10852528005466

ViperWire, Advance, Extended Length, Peripheral, 0.018" Dia spring tip, 475cm, 5 Pack
Cardiovascular Systems, Inc.
VPR-GW-EL18
In Commercial Distribution

  • 10852528005466 ()
  • 30852528005460 ()

  • Length: 475 Centimeter
  • Shaft Diameter 0.014 inches
  • Max Tip Diameter 0.018 inches
7-10035-02

  • Peripheral vascular guidewire, manual

Extended Length ViperWire Advance - 10852528005459

ViperWire, Advance, Extended Length, Peripheral, 0.014" Dia spring tip, 475cm, 5 Pack
Cardiovascular Systems, Inc.
VPR-GW-EL14
In Commercial Distribution

  • 30852528005453 ()
  • 10852528005459 ()

  • Length: 475 Centimeter
  • Shaft Diameter 0.014 inches
  • Max Tip Diameter 0.014 inches
7-10035-01

  • Peripheral vascular guidewire, manual

Diamondback Coronary - 10852528005442

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

  • 10852528005442 ()
7-10037-01

  • Atherectomy system saline/lubricant pump

Diamondback Peripheral - 10852528005008

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 - 10850026568698

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

FJ Clip 5 - 00883475951660

No Description
CHARMANT INC.
24-0001
In Commercial Distribution

  • 00883475951660 ()


  • Gastrointestinal endoscopic clip applier

Elation 5™ - 00884450487211

No Description
Merit Medical Systems, Inc.
00884450487211
In Commercial Distribution

  • 10884450487218 ()
  • 00884450487211 ()

  • Balloon Outer Diameters-17 mm, 18 mm, 19 mm, 20 mm, 21 mm
EPCX18

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

Elation 5™ - 00884450487204

No Description
Merit Medical Systems, Inc.
00884450487204
In Commercial Distribution

  • 10884450487201 ()
  • 00884450487204 ()

  • Balloon Outer Diameters-14 mm, 15 mm, 16.5 mm, 18 mm, 19 mm
EPCX15

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

Elation 5™ - 00884450487198

No Description
Merit Medical Systems, Inc.
00884450487198
In Commercial Distribution

  • 10884450487195 ()
  • 00884450487198 ()

  • Balloon Outer Diameters-11 mm, 12 mm, 13.5 mm, 15 mm, 16 mm
EPCX12

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

Elation 5™ - 00884450487181

No Description
Merit Medical Systems, Inc.
00884450487181
In Commercial Distribution

  • 10884450487188 ()
  • 00884450487181 ()

  • Balloon Outer Diameters-9 mm, 10 mm, 11 mm, 12 mm, 13 mm
EPCX10

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

Elation 5™ - 00884450487150

No Description
Merit Medical Systems, Inc.
00884450487150
In Commercial Distribution

  • 10884450487157 ()
  • 00884450487150 ()

  • Balloon Outer Diameters-7 mm, 8 mm, 9 mm, 10 mm, 11 mm
EPCX8

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

Elation 5™ - 00884450487136

No Description
Merit Medical Systems, Inc.
00884450487136
In Commercial Distribution

  • 10884450487133 ()
  • 00884450487136 ()

  • Balloon Outer Diameters-5 mm, 6 mm, 7 mm, 8 mm, 9 mm
EPCX6

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

Elation 5™ - 00884450487129

No Description
Merit Medical Systems, Inc.
00884450487129
In Commercial Distribution

  • 10884450487126 ()
  • 00884450487129 ()

  • Balloon Outer Diameters-17 mm, 18 mm, 19 mm, 20 mm, 21 mm
EPX18

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

Elation 5™ - 00884450487112

No Description
Merit Medical Systems, Inc.
00884450487112
In Commercial Distribution

  • 10884450487119 ()
  • 00884450487112 ()

  • Balloon Outer Diameters-14 mm, 15 mm, 16.5 mm, 18 mm, 19 mm
EPX15

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated

Elation 5™ - 00884450487099

No Description
Merit Medical Systems, Inc.
00884450487099
In Commercial Distribution

  • 10884450487096 ()
  • 00884450487099 ()

  • Balloon Outer Diameters-11 mm, 12 mm, 13.5 mm, 15 mm, 16 mm
EPX12

  • Gastrointestinal/biliary dilation balloon catheter, non-medicated
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