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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 CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT
Cardiovascular Systems, Inc.
DBEC-125
In Commercial Distribution

  • 10850026568100 ()

  • Crown diameter, 1.25mm
  • Nose Length, 5mm
  • Shaft Length, 135cm
  • Guidewire Size OD, 0.012 inches
  • Low Speed, 80 krpm
  • Medium Speed, krpm
  • High Speed, 120 krpm
  • Crown Type, Classic
  • Max OD, 0.0495
  • Intro Sheath, 6
7-10060-10

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

  • 10850026568087 ()

  • Crown diameter, 1.25mm
  • Nose Length, 5mm
  • Shaft length, 135cm
  • Guidewire size OD, 0.012 inches
  • Low Speed, 80 krpm
  • Medium Speed, krpm
  • High Speed, 120 krpm
  • Crown Type, Classic
  • Max OD, 0.0495 inches
  • Intro Sheath, 6Fr
7-10060-09

  • Mechanical atherectomy system, coronary, line-powered
0.018" Shepherd ES Guidewire - straight 300 cm - 6 gms
Cardiovascular Systems, Inc.
PSP18S-30006
In Commercial Distribution

  • 30850026568609 ()
  • 10850026568605 ()

  • Guidewire Diameter: 0.018 Inch
  • Length: 300 Centimeter
  • Hydorphilic Coating
  • Tip Flex 6 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10096-08

  • Peripheral vascular guidewire, manual
0.014" Shepherd ES Guidewire - straight 300 cm - 6 gms
Cardiovascular Systems, Inc.
PSP14S-30006
In Commercial Distribution

  • 30850026568586 ()
  • 10850026568582 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 300 Centimeter
  • Hydrophilic Coating
  • Tip Flex 6 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10096-06

  • Peripheral vascular guidewire, manual
0.018" Shepherd ES Guidewire - straight 300 cm - 4 gms
Cardiovascular Systems, Inc.
PSP18S-30004
In Commercial Distribution

  • 30850026568562 ()
  • 10850026568568 ()

  • Guidewire Diameter: 0.018 Inch
  • Length: 300 Centimeter
  • Hydrophilic Coating
  • Tip Flex 4 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10096-04

  • Peripheral vascular guidewire, manual
0.014" Shepherd ES Guidewire - straight 300 cm - 4 gms
Cardiovascular Systems, Inc.
PSP14S-30004
In Commercial Distribution

  • 10850026568544 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 300 Centimeter
  • Hydrophilic Coating
  • Tip Flex 4 grams
  • Tip Shape Straighht
  • Tip Design Polymer Jacket
7-10096-02

  • Peripheral vascular guidewire, manual
Diamondback Peripheral, Exchangeable Series, Cartridge, 1.50 Solid, 200 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-150SOL200
In Commercial Distribution

  • 10852528005992 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.063 inches
  • Crown Type: Solid
  • High Speed: 120krpm
  • Medium Speed: 90krpm
  • Low Speed: 60krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 200cm
  • Nose Length: 10mm
  • Crown Diameter: 1.50mm
7-10031-08

  • Mechanical atherectomy system catheter, peripheral
Diamondback Peripheral, Exchangeable Series, Cartridge, 1.25 Solid, 200 cm shaft
Cardiovascular Systems, Inc.
DBP-CART-125SOL200
In Commercial Distribution

  • 10852528005985 ()

  • Intro Sheath: 4 Fr
  • Max OD: 0.063 inches
  • Crown Type: Solid
  • High Speed: 120krpm
  • Medium Speed: 90krpm
  • Low Speed: 60krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 200cm
  • Nose Length: 10mm
  • Crown Diameter: 1.25mm
7-10031-07

  • Mechanical atherectomy system catheter, peripheral
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, 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
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