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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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The device is intended as a computer platform to perform computation, display, connectivity and user input functions for CLEAR GUIDE image guidance software (e.g., Clear Guide SCENERGY). The device facilitates rigid, needle-like surgical instrument tracking and guidance feedback for diagnostic and interventional procedures in a clinical setting. The CG-CORE13 model is a tablet PC with a 13" screen.
CLEAR GUIDE MEDICAL, INC.
CGCORE13
In Commercial Distribution

  • B201CGCORE130 ()
  • B201CGCORE131 ()
CG-CORE-13

  • Ultrasound imaging system workstation
  • Stereotactic surgery system workstation
  • Optical surgical navigation device tracking system workstation, mobile
  • Portable computer
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
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
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
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 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
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