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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™ - 00813132020194

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
423-135-01AA
In Commercial Distribution

  • M20442313501AA0 ()
  • 00813132020194 ()

  • Outer Diameter: 2.3 Millimeter
423-135-01

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - 00813132020187

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
425-011AA
In Commercial Distribution

  • M204425011AA0 ()
  • 00813132020187 ()

  • Outer Diameter: 2.6 Millimeter
425-011

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - 00813132020170

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
423-001AA
In Commercial Distribution

  • M204423001AA0 ()
  • 00813132020170 ()

  • Outer Diameter: 2.3 Millimeter
423-001

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - 00813132020163

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
420-159AA
In Commercial Distribution

  • M204420159AA0 ()
  • 00813132020163 ()

  • Outer Diameter: 2.0 Millimeter
420-159

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - 00813132020156

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
420-006AA
In Commercial Distribution

  • M204420006AA0 ()
  • 00813132020156 ()

  • Outer Diameter: 2.0 Millimeter
420-006

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - 00813132020149

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
417-156AA
In Commercial Distribution

  • M204417156AA0 ()
  • 00813132020149 ()

  • Outer Diameter: 1.75 Millimeter
417-156

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - 00813132020132

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
417-152AA
In Commercial Distribution

  • M204417152AA0 ()
  • 00813132020132 ()

  • Outer Diameter: 1.73 Millimeter
417-152

  • Atherectomy laser system beam guide-catheter, peripheral

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

JEM 350 Endotracheal Tube Changer - M996JEM3500

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 350 fits tubes with 5.0mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 350
In Commercial Distribution

  • M996JEM3502 ()
  • M996JEM3500 ()

  • Outer Diameter: 4.55 Millimeter
JEM 350

  • Endotracheal tube guide, single-use

JEM 340 Endotracheal Tube Changer - M996JEM3400

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 340 fits tubes with 4.0mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 340
In Commercial Distribution

  • M996JEM3402 ()
  • M996JEM3400 ()

  • Outer Diameter: 3.56 Millimeter
JEM 340

  • Endotracheal tube guide, single-use

JEM 330 Endotracheal Tube Changer - M996JEM3300

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 330 fits tubes with 3.0mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 330
In Commercial Distribution

  • M996JEM3302 ()
  • M996JEM3300 ()

  • Outer Diameter: 2.57 Millimeter
JEM 330

  • Endotracheal tube guide, single-use

JEM 325 Endotracheal Tube Changer - M996JEM3250

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 325 fits tubes with 2.5mm Inside Diameter.
INSTRUMENTATION INDUSTRIES, INCORPORATED
JEM 325
In Commercial Distribution

  • M996JEM3252 ()
  • M996JEM3250 ()

  • Outer Diameter: 1.80 Millimeter
JEM 325

  • Endotracheal tube guide, single-use

NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter - NRP368

The device is the Phillips 0.9mm OTW Turbo Elite Laser Atherectomy catheter that is reprocessed by Northeast Scientific, Inc. (NES).
NORTH EAST SCIENTIFIC INC
R-410-152
Not in Commercial Distribution

  • NRP368 ()

  • Catheter Working Length: 150 Centimeter
  • Lumen/Inner Diameter: .014 Inch
  • Guidewire Compatibility: 4 French
R-410-152

  • Atherectomy laser system beam guide-catheter, peripheral

PEDIMAG BLOOD PUMP - 07640135140634

No Description
Thoratec Switzerland GmbH
201-90052
In Commercial Distribution

  • 07640135140634 ()
201-90052

  • Cardiopulmonary bypass system centrifugal pump

CentriMag™ - 07640135140627

Blood Pump
Thoratec Switzerland GmbH
102953
In Commercial Distribution

  • 07640135140627 ()
102953

  • Cardiopulmonary bypass system centrifugal pump

HUDSON RCI - 04026704588626

ET TUBE, EXCHANGER, ETX, 35 - 41 FR
TELEFLEX INCORPORATED
IPN044923
In Commercial Distribution

  • 24026704588620 ()
  • 04026704588626 ()
  • 44026704588624 ()

  • Length: 1000 Millimeter
  • Sheridan E.T.X. Endobronchial Tube Exchanger
5-24105

  • Endotracheal tube guide, single-use

Affinity™ CP - 00763000301323

ADAPTER AP40AST AFFINITY CP WW 31L
MEDTRONIC, INC.
AP40AST
In Commercial Distribution

  • 00763000301323 ()

  • Outer Diameter: 94.0 Millimeter
  • Height: 28.0 Millimeter
  • Weight: 315.0 Gram


  • Cardiopulmonary bypass system centrifugal pump

Turbo-Elite™ - M2044171560

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
417-156
Not in Commercial Distribution

  • M2044171560 ()

  • Outer Diameter: 1.75 Millimeter
417-156

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - M2044171520

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
417-152
Not in Commercial Distribution

  • M2044171520 ()

  • Outer Diameter: 1.73 Millimeter
417-152

  • Atherectomy laser system beam guide-catheter, peripheral

Affinity™ CP - 20763000074412

PUMP CBAP40 AFFINITY CP CENTRIFUGAL CC
MEDTRONIC, INC.
CBAP40
In Commercial Distribution

  • 20763000074412 ()
  • 00763000074418 ()


  • Cardiopulmonary bypass system centrifugal pump

Turbo Tandem™ - M2044821100

Turbo-Tandem™ Laser Guide Catheter with Laser Atherectomy Catheter
Spectranetics Corporation
482-110
Not in Commercial Distribution

  • M2044821100 ()

  • Length: 110 Centimeter
482-110

  • Atherectomy laser system beam guide-catheter, peripheral
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