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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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Neuroguard IEP® System - 00851616007590

The Neuroguard IEP System consists of three main components: • A self-expanding nitinol stent • A delivery catheter which includes a post-dilation balloon and activation handle • Embolic protection filter that is integrated at the distal end of the delivery system
Contego Medical, Inc.
NG-0640-140-2
In Commercial Distribution

  • 00851616007590 ()
NG-0640-140-2

  • Peripheral angioplasty balloon catheter, basic
  • Carotid artery embolic protection system
  • Bare-metal carotid artery stent

Neuroguard IEP® System - 00851616007583

The Neuroguard IEP System consists of three main components: • A self-expanding nitinol stent • A delivery catheter which includes a post-dilation balloon and activation handle • Embolic protection filter that is integrated at the distal end of the delivery system
Contego Medical, Inc.
NG-0630-140-2
In Commercial Distribution

  • 00851616007583 ()
NG-0630-140-2

  • Bare-metal carotid artery stent
  • Carotid artery embolic protection system
  • Peripheral angioplasty balloon catheter, basic

ACCU-CHEK GUIDE LINK - 00365702702417

ACCU-CHEK GUIDE LINK MG/DL 118
Roche Diagnostics Operations, Inc.
08109257002
In Commercial Distribution

  • 00365702702417 ()
08109257002

  • Glucose analyser IVD, home-use

Avanta CMC - 00886385025728

CMC, Trapezial Burr Size 20, 6mm
Stryker GmbH
17-0486
In Commercial Distribution

  • 00886385025728 ()

  • SIZE 20, Trapezium
  • Outer Diameter: 6 Millimeter


  • Orthopaedic bur, reusable

Vysis - 00884999042773

Vysis ALK Break Apart FISH Probe Kit
ABBOTT MOLECULAR INC.
06N38-053
In Commercial Distribution

  • 00884999042773 ()
06N38-053

  • Anaplastic lymphoma kinase (ALK) genetic mutation IVD, probe

Vysis - 00884999042728

Vysis ALK Break Apart FISH Probe Kit
ABBOTT MOLECULAR INC.
06N38-033
In Commercial Distribution

  • 00884999042728 ()
06N38-033

  • Anaplastic lymphoma kinase (ALK) genetic mutation IVD, probe

Vysis - 00884999025745

Vysis ALK Break Apart FISH Probe Kit
ABBOTT MOLECULAR INC.
06N38-020
In Commercial Distribution

  • 00884999025745 ()
06N38-020

  • Anaplastic lymphoma kinase (ALK) genetic mutation IVD, probe

NA - 00643169023796

WRENCH 1036W 1 1/8 FOR CRYOCONSOLE
MEDTRONIC, INC.
1036W
In Commercial Distribution

  • 00643169023796 ()


  • Cardiac cryosurgical system

SJM™ - 05414734506823

SLIT SUTURE SLEEVE (4.3 - 4.7F)
ST. JUDE MEDICAL, INC.
DSA0006
In Commercial Distribution

  • 05414734506823 ()

  • Catheter Gauge: 4.5 French
DSA0006

  • Implantable electrical stimulation lead suture sleeve

SJM™ - 05414734504973

SUTURE SLEEVE
ST. JUDE MEDICAL, INC.
DS0A001
In Commercial Distribution

  • 05414734504973 ()

  • Catheter Gauge: 7 French
DS0A001

  • Implantable electrical stimulation lead suture sleeve
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