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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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The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, straight
In Commercial Distribution

  • 04047844114339 ()

  • 6x9x20mm
TRT00060920

  • Metallic spinal interbody fusion cage
The SIGNUS TETRIS™ ST and SIGNUS TETRIS™ R ST system is an intervertebral fusion device to treat degenerative disc disease. The implants are additively manufactured from titanium alloy (Ti-6Al-4V). Each device is available in a single footprint, with multiple heights and angulations. The SIGNUS TETRIS™ ST/ TETRIS™ R ST device is placed by a PLIF (Posterior Lumbar Interbody Fusion) approach in the L2 – S1 spinal region and should be inserted in pairs. The device is comprised of structural titanium in an open-pore grid structure. The large fenestration in the implant permits the cage to be packed with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
SIGNUS Medizintechnik GmbH
Lumbar cage, straight
In Commercial Distribution

  • 04047844114322 ()

  • 8x9x20mm
TRT00080920

  • Metallic spinal interbody fusion cage
Femoral Venous Cannula
Edwards Lifesciences LLC
FTV024
In Commercial Distribution

  • 00690103180138 ()

  • 24 Fr. (8.0 mm) x 68 cm (26.8")
FTV024

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
Femoral Venous Cannula
Edwards Lifesciences LLC
FTV020
In Commercial Distribution

  • 00690103180121 ()

  • 20 Fr. (6.7 mm) x 55 cm (21.6")
FTV020

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
FEM-FLEX II Femoral Arterial Cannula
Edwards Lifesciences LLC
FEMII020AS
In Commercial Distribution

  • 00690103168365 ()

  • 20 Fr. (6.7 mm) x 15 cm (6")
FEMII020AS

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
FEM-FLEX II Femoral Arterial Cannula
Edwards Lifesciences LLC
FEMII018AS
In Commercial Distribution

  • 00690103168358 ()

  • 18 Fr. (6.0 mm) x 15 cm (6")
FEMII018AS

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
FEM-FLEX II Femoral Arterial Cannula
Edwards Lifesciences LLC
FEMII016AS
In Commercial Distribution

  • 00690103168341 ()

  • 16 Fr. (5.3 mm) x 15 cm (6")
FEMII016AS

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
Femoral Venous Cannula
Edwards Lifesciences LLC
VFEM028
In Commercial Distribution

  • 00690103146684 ()

  • 28 Fr. (9.3 mm) x 68 cm (26.8")
VFEM028

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
Femoral Venous Cannula
Edwards Lifesciences LLC
VFEM024
In Commercial Distribution

  • 00690103146677 ()

  • 24 Fr. (8.0 mm) x 68 cm (26.8")
VFEM024

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
Femoral Venous Cannula
Edwards Lifesciences LLC
VFEM022
In Commercial Distribution

  • 00690103146660 ()

  • 22 Fr. (7.3 mm) x 55 cm (21.6")
VFEM022

  • Cardiopulmonary bypass/extracorporeal membrane oxygenation cannula, drainage
  • Cardiopulmonary bypass cannula, femoral
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