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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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CERTEX 4.5 X 24mm THREADED X 10mm SMOOTH X 34mm OVERALL SMOOTH SHANK SCREW ASSEMBLY
Xtant Medical Holdings, Inc.
X067-0294
Not in Commercial Distribution

  • M697X06702941 ()

  • Length: 34 Millimeter
  • Length: 24 Millimeter
  • Length: 10 Millimeter
  • Outer Diameter: 4.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
CERTEX 4.5 X 16mm THREADED X 8mm SMOOTH X 24mm OVERALL SMOOTH SHANK SCREW ASSEMBLY
Xtant Medical Holdings, Inc.
X067-0280
Not in Commercial Distribution

  • M697X06702801 ()

  • Length: 8 Millimeter
  • Length: 16 Millimeter
  • Length: 24 Millimeter
  • Outer Diameter: 4.5 Millimeter


  • Spinal bone screw, non-bioabsorbable
CERTEX 3.5 X 24mm THREADED X 16mm SMOOTH X 40mm OVERALL SMOOTH SHANK SCREW ASSEMBLY
Xtant Medical Holdings, Inc.
X067-0266
Not in Commercial Distribution

  • M697X06702661 ()

  • Length: 16 Millimeter
  • Outer Diameter: 3.5 Millimeter
  • Length: 24 Millimeter
  • Length: 40 Millimeter


  • Spinal bone screw, non-bioabsorbable
CERTEX 3.5 X 24mm THREADED X 13mm SMOOTH X 37mm OVERALL SMOOTH SHANK SCREW ASSEMBLY
Xtant Medical Holdings, Inc.
X067-0265
Not in Commercial Distribution

  • M697X06702651 ()

  • Length: 37 Millimeter
  • Length: 24 Millimeter
  • Outer Diameter: 3.5 Millimeter
  • Length: 13 Millimeter


  • Spinal bone screw, non-bioabsorbable
CERTEX 3.5 X 24mm THREADED X 10mm SMOOTH X 34mm OVERALL SMOOTH SHANK SCREW ASSEMBLY
Xtant Medical Holdings, Inc.
X067-0264
Not in Commercial Distribution

  • M697X06702641 ()

  • Length: 10 Millimeter
  • Length: 34 Millimeter
  • Outer Diameter: 3.5 Millimeter
  • Length: 24 Millimeter


  • Spinal bone screw, non-bioabsorbable
CERTEX 3.5 X 16mm THREADED X 8mm SMOOTH X 24mm OVERALL SMOOTH SHANK SCREW ASSEMBLY
Xtant Medical Holdings, Inc.
X067-0250
Not in Commercial Distribution

  • M697X06702501 ()

  • Outer Diameter: 3.5 Millimeter
  • Length: 24 Millimeter
  • Length: 8 Millimeter
  • Length: 16 Millimeter


  • Spinal bone screw, non-bioabsorbable
CTAG CMDS 45MMX37MMX15CM 24Fr
W. L. Gore & Associates, Inc.
TGM453715
In Commercial Distribution

  • 00733132661671 ()

  • Length: 15 Centimeter
  • Catheter Gauge: 24 French
  • Lumen/Inner Diameter: 37 Millimeter
  • Lumen/Inner Diameter: 45 Millimeter
TGM453715

  • Descending thoracic aorta endovascular stent-graft
Endovascular stent-graft system
Bolton Medical Inc.
28-M328195242290U
Not in Commercial Distribution

  • 08435761002260 ()

  • Catheter Gauge: 22 French
  • Outer Diameter: 28 Millimeter
  • Length: 195 Millimeter
  • Outer Diameter: 24 Millimeter
28-M328195242290U

  • Descending thoracic aorta endovascular stent-graft
Endovascular Stent-Graft System
Bolton Medical Inc.
28-B2-24-120U
Not in Commercial Distribution

  • 08435761052500 ()

  • Outer Diameter: 24 Millimeter
  • Outer Diameter: 14 Millimeter
  • Length: 120 Millimeter
  • Catheter Gauge: 18 French
28-B2-24-120U

  • Abdominal aorta endovascular stent-graft
Endovascular Stent-Graft System
Bolton Medical Inc.
28-B2-24-100U
Not in Commercial Distribution

  • 08435761052425 ()

  • Outer Diameter: 24 Millimeter
  • Outer Diameter: 14 Millimeter
  • Length: 100 Millimeter
  • Catheter Gauge: 18 French
28-B2-24-100U

  • Abdominal aorta endovascular stent-graft
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