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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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t:slim G4 Cartridge 10 Pack - 00852162004415

The #1-rated insulin pump is now integrated with the #1-rated Continuous Glucose Monitoring brand that set the standard for accuracy and performance in sensor-augmented pumps. The t:slim G4 Pump is the only pump that conveniently combines CGM graphs and trend information with current insulin delivery together on a single color touch screen to help you make more informed decisions.
Tandem Diabetes Care, Inc.
007526
In Commercial Distribution

  • 00852162004415 ()
  • 10852162004412 ()

  • Total Volume: 3 Milliliter


  • Ambulatory insulin infusion pump reservoir

t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM - 00852162004408

The #1-rated insulin pump is now integrated with the #1-rated Continuous Glucose Monitoring brand that set the standard for accuracy and performance in sensor-augmented pumps. The t:slim G4 Pump is the only pump that conveniently combines CGM graphs and trend information with current insulin delivery together on a single color touch screen to help you make more informed decisions.
Tandem Diabetes Care, Inc.
006194
In Commercial Distribution

  • 00852162004408 ()


  • Ambulatory insulin infusion pump/blood glucose analyser system

Mara Console - 00857379006023

The Mara Console guides the physician through the procedure by use of a graphical user interface; regulates the creation of water vapor in the Water Vapor Probe; and provides automated real-time monitoring and active management throughout the procedure.
AEGEA MEDICAL INC.
GEN-16-050
In Commercial Distribution

  • 00857379006023 ()
GEN-16-050

  • Water vapour endometrial-ablation control unit

Cross-Seal - 04719872920380

The Cross-Seal Accessories (Cross-Seal Knot Tyer, Cross-Seal Knot Pusher, and Cross-Seal Suture Trimmer) are designed to tie the knots, position the knot to the top of the arteriotomy, and to trim the trailing limbs of the suture, respectively.
MEDEON BIODESIGN, INC.
002
In Commercial Distribution

  • 04719872920380 ()
  • 04719872920397 ()
  • 04719872920403 ()
002

  • Polyolefin/fluoropolymer suture, monofilament

Neuroguard IEP® System - 00851616007651

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-NV-6-40
In Commercial Distribution

  • 00851616007651 ()
NG-NV-6-40

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

Neuroguard IEP® System - 00851616007644

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-NV-6-30
In Commercial Distribution

  • 00851616007644 ()
NG-NV-6-30

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

Neuroguard IEP® System - 00851616007637

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-NV-7-30
In Commercial Distribution

  • 00851616007637 ()
NG-NV-7-30

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

Neuroguard IEP® System - 00851616007620

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-NV-7-40
In Commercial Distribution

  • 00851616007620 ()
NG-NV-7-40

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

Neuroguard IEP® System - 00851616007613

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-0740-140-2
In Commercial Distribution

  • 00851616007613 ()
NG-0740-140-2

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

Neuroguard IEP® System - 00851616007606

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-0730-140-2
In Commercial Distribution

  • 00851616007606 ()
NG-0730-140-2

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