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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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INTEGRA® - 00650551141877

TISSUE EXPANDER, CURVE, SMOOTH, 2-STAGE, INTERNAL RESEAL PORT
PMT CORPORATION
3614-544-2IR
In Commercial Distribution

  • 00650551141877 ()

  • Projection 10 Centimeter
  • Total Volume: 1897 Centiliter
  • Length: 24 Centimeter
  • Width: 10 Centimeter
3614-544-2IR

  • Skin-port tissue expander

ConvertX™ Nephroureteral Stent System - 00851571007369

No Description
BRIGHTWATER MEDICAL, INC.
8.3F - 10.3F Taper x 24cm
Not in Commercial Distribution

  • 00851571007369 ()

  • Catheter Gauge: 8.3 French
  • Length: 24 Centimeter
  • Catheter Gauge: 10.3 French
100081-24

  • Polymeric ureteral stent

INTEGRA® - 00650551096283

TISSUE EXPANDER, RECTANGLE, SUTURE TABS
PMT CORPORATION
3610-601-ST
In Commercial Distribution

  • 00650551096283 ()

  • Projection 6 Centimeter
  • Total Volume: 650 Centiliter
  • Length: 24 Centimeter
  • Width: 6 Centimeter
3610-601-ST

  • Skin-port tissue expander

TREO Abdominal Stent-Graft System - 08435761052746

Endovascular Stent-Graft System
Bolton Medical Inc.
28-C2-24-070U
Not in Commercial Distribution

  • 08435761052746 ()

  • Outer Diameter: 24 Millimeter
  • Length: 70 Millimeter
  • Catheter Gauge: 18 French
28-C2-24-070U

  • Abdominal aorta endovascular stent-graft

TREO Abdominal Stent-Graft System - 08435761052661

Endovascular Stent-Graft System
Bolton Medical Inc.
28-C2-24-055U
Not in Commercial Distribution

  • 08435761052661 ()

  • Outer Diameter: 24 Millimeter
  • Length: 55 Millimeter
  • Catheter Gauge: 18 French
28-C2-24-055U

  • Abdominal aorta endovascular stent-graft

TREO Abdominal Stent-Graft System - 08435761052586

Endovascular Stent-Graft System
Bolton Medical Inc.
28-C2-24-040U
Not in Commercial Distribution

  • 08435761052586 ()

  • Outer Diameter: 24 Millimeter
  • Length: 40 Millimeter
  • Catheter Gauge: 18 French
28-C2-24-040U

  • Abdominal aorta endovascular stent-graft

Relay Plus Thoracic Stent-Graft System - 08435761001652

Endovascular stent-graft system
Bolton Medical Inc.
28-M324090242290U
Not in Commercial Distribution

  • 08435761001652 ()

  • Catheter Gauge: 22 French
  • Outer Diameter: 24 Millimeter
  • Length: 90 Millimeter
28-M324090242290U

  • Descending thoracic aorta endovascular stent-graft

Relay Plus Thoracic Stent-Graft System - 08435761002109

Endovascular stent-graft system
Bolton Medical Inc.
28-M336250362490U
Not in Commercial Distribution

  • 08435761002109 ()

  • Outer Diameter: 36 Millimeter
  • Length: 250 Millimeter
  • Catheter Gauge: 24 French
28-M336250362490U

  • Descending thoracic aorta endovascular stent-graft

Relay Plus Thoracic Stent-Graft System - 08435761002093

Endovascular stent-graft system
Bolton Medical Inc.
28-M334250342490U
Not in Commercial Distribution

  • 08435761002093 ()

  • Outer Diameter: 34 Millimeter
  • Length: 250 Millimeter
  • Catheter Gauge: 24 French
28-M334250342490U

  • Descending thoracic aorta endovascular stent-graft

Relay Plus Thoracic Stent-Graft System - 08435761002086

Endovascular stent-graft system
Bolton Medical Inc.
28-M332250322490U
Not in Commercial Distribution

  • 08435761002086 ()

  • Outer Diameter: 32 Millimeter
  • Length: 250 Millimeter
  • Catheter Gauge: 24 French
28-M332250322490U

  • Descending thoracic aorta endovascular stent-graft
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