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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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Affinity™ - 00763000134532

PUMP AP40 AFFINITY CP CENTRIFUGAL NC
MEDTRONIC, INC.
AP40
In Commercial Distribution

  • 20763000134536 ()
  • 00763000134532 ()


  • 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

Turbo Elite™ - M204425135010

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
425-135-01
Not in Commercial Distribution

  • M204425135010 ()

  • Outer Diameter: 2.6 Millimeter
425-135-01

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - M2044250010

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
425-011
Not in Commercial Distribution

  • M2044250010 ()

  • Outer Diameter: 2.6 Millimeter
425-011

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - M2044230010

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
423-001
Not in Commercial Distribution

  • M2044230010 ()

  • Outer Diameter: 2.3 Millimeter
423-001

  • 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

Turbo-Elite™ - M2044101540

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
410-154
Not in Commercial Distribution

  • M2044101540 ()

  • Outer Diameter: 0.97 Millimeter
410-154

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo Tandem™ - M2044721100

Turbo-Tandem™ Laser Guide Catheter with Laser Atherectomy Catheter
Spectranetics Corporation
472-110
Not in Commercial Distribution

  • M2044721100 ()

  • Length: 110 Centimeter
472-110

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo Elite™ - M204423135010

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
423-135-01
Not in Commercial Distribution

  • M204423135010 ()

  • Outer Diameter: 2.3 Millimeter
423-135-01

  • Atherectomy laser system beam guide-catheter, peripheral

Turbo-Elite™ - M2044201590

Turbo-Elite™ Laser Atherectomy Catheter
Spectranetics Corporation
420-159
Not in Commercial Distribution

  • M2044201590 ()

  • Outer Diameter: 2.0 Millimeter
420-159

  • Atherectomy laser system beam guide-catheter, peripheral
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