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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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GORE TAG Thoracic Branch Endoprosthesis - 00733132654093

TAG TBE AORTIC COMPONENT TAG TBE AC 8MMX34MMX15CM
W. L. Gore & Associates, Inc.
TAC083415A
In Commercial Distribution

  • 00733132654093 ()

  • Catheter Gauge: 24 French
  • Length: 15 Centimeter
  • Lumen/Inner Diameter: 34 Millimeter
TAC083415A

  • Aortic arch endovascular stent-graft

Certex Spinal Fixation System - M697X06715561

CERTEX 4.0 X 24mm THREADED X 16mm SMOOTH X 40mm OVERALL SMOOTH SHANK SCREW ASSEMBLY
Xtant Medical Holdings, Inc.
X067-1556
Not in Commercial Distribution

  • M697X06715561 ()

  • Length: 24 Millimeter
  • Length: 16 Millimeter
  • Outer Diameter: 4 Millimeter


  • Spinal bone screw, non-bioabsorbable

Certex Spinal Fixation System - M697X06715551

CERTEX 4.0 X 24mm THREADED X 13mm SMOOTH X 37mm OVERALL SMOOTH SHANK SCREW ASSEMBLY
Xtant Medical Holdings, Inc.
X067-1555
Not in Commercial Distribution

  • M697X06715551 ()

  • Outer Diameter: 4 Millimeter
  • Length: 13 Millimeter
  • Length: 24 Millimeter


  • Spinal bone screw, non-bioabsorbable

Certex Spinal Fixation System - M697X06715541

CERTEX 4.0 X 24mm THREADED X 10mm SMOOTH X 34mm OVERALL SMOOTH SHANK SCREW ASSEMBLY
Xtant Medical Holdings, Inc.
X067-1554
Not in Commercial Distribution

  • M697X06715541 ()

  • Length: 24 Millimeter
  • Outer Diameter: 4 Millimeter
  • Length: 10 Millimeter


  • Spinal bone screw, non-bioabsorbable

Hemagard - 00384401014423

Hemagard Knitted Bifurcated Collagen Coated Vascular Graft
INTERVASCULAR SAS
HGK2412
In Commercial Distribution

  • 00384401014423 ()

  • Lumen/Inner Diameter: 12 Millimeter
  • Lumen/Inner Diameter: 24 Millimeter
  • Length: 50 Centimeter
HGK2412

  • Synthetic vascular graft

Intergard - 00384401000594

Intergard Woven Bifurcated Collagen Coated Vascular Graft
INTERVASCULAR SAS
IGW2412
In Commercial Distribution

  • 00384401000594 ()

  • Lumen/Inner Diameter: 12 Millimeter
  • Lumen/Inner Diameter: 24 Millimeter
  • Length: 50 Centimeter
IGW2412

  • Synthetic vascular graft

Intergard - 00384401000525

Intergard Knitted Bifurcated Collagen Coated Vascular Graft
INTERVASCULAR SAS
IGK2412
In Commercial Distribution

  • 00384401000525 ()

  • Lumen/Inner Diameter: 12 Millimeter
  • Lumen/Inner Diameter: 24 Millimeter
  • Length: 50 Centimeter
IGK2412

  • Synthetic vascular graft

Endopyelotomy Stent with SL-6® Hydrophilic Coating - 00607915111946

Temporary indwelling ureteral catheter to assist in urine draining.
APPLIED MEDICAL RESOURCES CORPORATION
B3304
Not in Commercial Distribution

  • 00607915111946 ()

  • Length: 24 Centimeter
  • Catheter Gauge: 10 French
  • Catheter Gauge: 7 French


  • Polymeric ureteral stent

Hemashield - 00384401018551

Hemashield Platinum Woven 1 Branch Aortic Arch Double Velour Vascular Graft with Graft Sizer Accessory
INTERVASCULAR SAS
M00202175824P0
In Commercial Distribution

  • 00384401018551 ()

  • Lumen/Inner Diameter: 10 Millimeter
  • Lumen/Inner Diameter: 24 Millimeter
  • Length: 50 Centimeter
M00202175824P0

  • Synthetic vascular graft

Hemashield - 00384401018520

Hemashield Platinum Woven Bifurcated Double Velour Vascular Graft with Graft Sizer Accessory
INTERVASCULAR SAS
M00202166241P0
In Commercial Distribution

  • 00384401018520 ()

  • Lumen/Inner Diameter: 12 Millimeter
  • Lumen/Inner Diameter: 24 Millimeter
  • Length: 40 Centimeter
M00202166241P0

  • Synthetic vascular graft
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