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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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ViperCross Support Catheter, 035", 90cm, Straight
Cardiovascular Systems, Inc.
P1VC-035STR-090
Not in Commercial Distribution

  • 10850026568193 ()

  • Guidewire Compatability: 0.035 Inches
  • Shaft Diameter: 0.056 Inches
  • Length: 90cm
  • Tip Shape: Straight
7-10094-02

  • Vascular microcatheter
ViperCross Support Catheter, 018", 150cm, Straight
Cardiovascular Systems, Inc.
P1VC-018STR-150
Not in Commercial Distribution

  • 10850026568179 ()

  • Guidewire Compatability: 0.018 Inches
  • Shaft Diameter: 0.0375 Inches
  • Length: 150cm
  • Tip Shape: Straight
7-10093-04

  • Vascular microcatheter
ViperCross Support Catheter, 018", 90cm, Straight
Cardiovascular Systems, Inc.
P1VC-018STR-090
Not in Commercial Distribution

  • 10850026568155 ()

  • Guidewire Compability: 0.018 Inches
  • Shaft Diameter: 0.0375 Inches
  • Length: 90cm
  • Tip Shape: Straight
7-10093-02

  • Vascular microcatheter
ViperCross Support Catheter, 014", 135cm, Straight
Cardiovascular Systems, Inc.
P1VC-014STR-135
Not in Commercial Distribution

  • 10850026568124 ()

  • Guidewire Compatability: 0.014 Inches
  • Shaft Diameter: 0.0375 Inches
  • Length: 135cm
  • Tip Shape: Straight
7-10092-01

  • Vascular microcatheter
Wirion Embolic Protection System
Cardiovascular Systems, Inc.
WRN-D6
In Commercial Distribution

  • 10850000491882 ()

  • Deployed Filter Unit Length 22.5 mm
  • Deployed Filter Diameter 3.5-6.0 mm
  • Distal tip to strain relief (usable length) - delivery 144 cm
  • Rapid Exchange (RX) length - delivery 38 cm
  • Maximum catheter diameter - delivery 1.14 mm
  • Distal tip to strain relief (usable length) - retrieval 145 cm
  • Rapid Exchange (RX) length - retrieval 31 cm
  • Maximum catheter diameter - retrieval 1.67 mm
7-10078-01

  • Embolic protection filtering guidewire
SALINE INFUSION PUMP (SIP)
Cardiovascular Systems, Inc.
SIP-3000
In Commercial Distribution

  • 10852528005442 ()
7-10037-01

  • Atherectomy system saline/lubricant pump
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
Airo™ CPAP Mask Liners - Box of 25 - Large
Athfar 828 Inc
AL-25
In Commercial Distribution

  • 00850054813343 ()
  • 00850054813381 ()


  • General-purpose medical fibre padding
Airo™ CPAP Mask Liners - Box of 25 - Small
Athfar 828 Inc
AS-25
In Commercial Distribution

  • 00850054813350 ()
  • 00850054813374 ()


  • General-purpose medical fibre padding
Airo™ CPAP Mask Liners - Box of 25 - Medium
Athfar 828 Inc
AM-25
In Commercial Distribution

  • 00850054813336 ()
  • 00850054813367 ()


  • General-purpose medical fibre padding
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