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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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Turbo-Elite™ - 00813132020125

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
414-159AA
In Commercial Distribution

  • M204414159AA0 ()
  • 00813132020125 ()

  • Outer Diameter: 1.45 Millimeter
414-159

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - 00813132020118

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
414-151AA
In Commercial Distribution

  • M204414151AA0 ()
  • 00813132020118 ()

  • Pore Size: 1.40 Millimeter
414-151

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - 00813132020101

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
410-154AA
In Commercial Distribution

  • M204410154AA0 ()
  • 00813132020101 ()

  • Outer Diameter: 0.97 Millimeter
410-154

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - 00813132020095

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
410-152AA
In Commercial Distribution

  • M204410152AA0 ()
  • 00813132020095 ()

  • Outer Diameter: 0.97 Millimeter
410-152

  • Atherectomy laser system beam guide-catheter, peripheral

JEM 401 Set of Endotracheal Tube Changers, (includes 9 sizes) - M996JEM4010

JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. JEM 401 is a set of nine individually packaged endotracheal tube changers, with each fitting a different size endotracheal tube. The JEM 401 includes one each of JEM 325, JEM 330, JEM 340, JEM 350, JEM 355, JEM 360, JEM 365, JEM 370, JEM 400.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 401
In Commercial Distribution

  • M996JEM4010 ()

  • Outer Diameter: 6.43 Millimeter
  • Outer Diameter: 5.54 Millimeter
  • Outer Diameter: 4.55 Millimeter
  • Outer Diameter: 3.56 Millimeter
  • Outer Diameter: 2.57 Millimeter
  • Outer Diameter: 1.80 Millimeter
JEM 401

  • Endotracheal tube guide, single-use

JEM 400 Endotracheal Tube Changer - M996JEM4000

JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. JEM 400 fits tubes with 7.5mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 400
In Commercial Distribution

  • M996JEM4002 ()
  • M996JEM4000 ()

  • Outer Diameter: 6.43 Millimeter
JEM 400

  • Endotracheal tube guide, single-use

JEM 370 Endotracheal Tube Changer - M996JEM3700

JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. JEM 370 fits tubes with 7.0mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 370
In Commercial Distribution

  • M996JEM3702 ()
  • M996JEM3700 ()

  • Outer Diameter: 5.54 Millimeter
JEM 370

  • Endotracheal tube guide, single-use

JEM 365 Endotracheal Tube Changer - M996JEM3650

JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. JEM 365 fits tubes with 6.5mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 365
In Commercial Distribution

  • M996JEM3652 ()
  • M996JEM3650 ()

  • Outer Diameter: 5.54 Millimeter
JEM 365

  • Endotracheal tube guide, single-use

JEM 360 Endotracheal Tube Changer - M996JEM3600

JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. JEM 360 fits tubes with 6.0mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 360
In Commercial Distribution

  • M996JEM3602 ()
  • M996JEM3600 ()

  • Outer Diameter: 5.54 Millimeter
JEM 360

  • Endotracheal tube guide, single-use

JEM 355 Endotracheal Tube Changer - M996JEM3550

JEM Series Endotracheal Tube Changers provide a simple, rapid technique for changing endotracheal and orotracheal tubes, with specific inside diameters. JEM Series Endotracheal Tube Changers are intended for single patient use. JEM 355 fits tubes with 5.5mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 355
In Commercial Distribution

  • M996JEM3552 ()
  • M996JEM3550 ()

  • Outer Diameter: 4.55 Millimeter
JEM 355

  • Endotracheal tube guide, single-use
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