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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, 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
2F (0.7MM ID) X 2CM2F (0.7MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/60CM STEEL WIREW/60CM STEEL WI & 22GA SAFETY NEEDLE
Medical Components, Inc.
MR1902622S
Not in Commercial Distribution

  • 30884908104197 ()
  • 00884908104196 ()
  • 50884908104191 ()
MR1902622S

  • Vascular catheter introduction needle
2F (0.7MM ID) X 2CM2F (0.7MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/60CM STEEL WIREW/60CM STEEL WI & 24GA SAFETY NEEDLE
Medical Components, Inc.
MR1902624S
Not in Commercial Distribution

  • 30884908104180 ()
  • 00884908104189 ()
  • 50884908104184 ()
MR1902624S

  • Vascular catheter introduction needle
3F (1.1MM ID) X 3CM3F (1.1MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/60CM STEEL WIREW/60CM STEEL WI & 22GA SAFETY NEEDLE
Medical Components, Inc.
MR1903622S
Not in Commercial Distribution

  • 50884908104290 ()
  • 30884908104296 ()
  • 00884908104295 ()
MR1903622S

  • Vascular catheter introduction needle
3F (1.1MM ID) X 3CM3F (1.1MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/60CM STEEL WIREW/60CM STEEL WI & 24GA SAFETY NEEDLE
Medical Components, Inc.
MR1903624S
Not in Commercial Distribution

  • 50884908104283 ()
  • 30884908104289 ()
  • 00884908104288 ()
MR1903624S

  • Vascular catheter introduction needle
4-hour ID of Enterobacteriaceae. API®strips give accurate ID based on extensive databases and are standardized, easy-to-use test systems.
BIOMERIEUX SA
RAPID 20 E™
In Commercial Distribution

  • 03573026048617 ()
  • 03573026588526 ()


  • Multiple gram negative bacteria species culture isolate identification IVD, kit
7F (2.3MM ID) X 10CM7F (2.3MM ID TEARAWAY INTRODUCER SETTEARAWAY W/NITINOL GUIDEWIREW/NITINOL GUI W/RADIOPAQUE TIPW/RADIOPAQUE TIP
Medical Components, Inc.
DMR210780
Not in Commercial Distribution

  • 50884908145514 ()
  • 30884908145510 ()
  • 00884908145519 ()
DMR210780

  • Vascular catheter introduction needle
3F (1.0MM ID) X 5CM3F (1.0MM ID) TEARAWAY INTRODUCER SETTEARAWAY W/NITINOL GUIDEWIREW/NITINOL GUI W/RADIOPAQUE TIPW/RADIOPAQUE TIP
Medical Components, Inc.
DMR190300
Not in Commercial Distribution

  • 30884908145428 ()
  • 00884908145427 ()
  • 50884908145422 ()
DMR190300

  • Vascular catheter introduction needle
SAMPLE LINE,AGENT,MALE LUER,SPU,7',50/BOX
SPACELABS HEALTHCARE (WASHINGTON), INC
NIBP Hoses and adapters
In Commercial Distribution

  • 00841522127376 ()
  • 10841522127373 ()

  • 1.19mm ID, 213 cm length
162-0047-01

  • Patient monitoring system module, multiple-gas
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