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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Tissue Expander, Round, 3-Valves, Smooth, 400 ml
Sientra, Inc.
800-400U3
Not in Commercial Distribution

  • 00812790022342 ()

  • Total Volume: 400 Milliliter
800-400U3

  • Skin-port tissue expander
Tissue Expander, Round, 3-Valves, Smooth, 300 ml
Sientra, Inc.
800-300U3
Not in Commercial Distribution

  • 00812790022335 ()

  • Total Volume: 300 Milliliter
800-300U3

  • Skin-port tissue expander
Tissue Expander, Round, 3-Valves, Smooth, 200 ml
Sientra, Inc.
800-200U3
Not in Commercial Distribution

  • 00812790022328 ()

  • Total Volume: 200 Milliliter
800-200U3

  • Skin-port tissue expander
Tissue Expander, Round, 3-Valves, Smooth, 100 ml
Sientra, Inc.
800-100U3
Not in Commercial Distribution

  • 00812790022311 ()

  • Total Volume: 100 Milliliter
800-100U3

  • Skin-port tissue expander
Tissue Expander, Round, 3-Valves, Smooth, 50 ml
Sientra, Inc.
800-050U3
Not in Commercial Distribution

  • 00812790022304 ()

  • Total Volume: 50 Milliliter
800-050U3

  • Skin-port tissue expander
Collagen wound dressing
NOVABONE PRODUCTS, LLC
BH2200-S
In Commercial Distribution

  • 00813909010564 ()
  • 00813909010571 ()

  • Width: 10 Millimeter
  • Length: 20 Millimeter
BH2200-S

  • General oral wound dressing, animal-derived
Collagen wound dressing
NOVABONE PRODUCTS, LLC
BH2210
In Commercial Distribution

  • 00813909010267 ()
  • 00813909010540 ()

  • Width: 25 Millimeter
  • Depth: 1 Millimeter
  • Length: 75 Millimeter
BH2210

  • General oral wound dressing, animal-derived
primaLOK FF 35mm Implant Assembly, Sterile The Wenzel Spine primaLOK FF Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is intended for use with or without bone graft, at a single or multiple levels from L1 to S1 inclusive. It is indicated for the posterior surgical treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the facets with instability, trauma (i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and pseudoarthrosis and failed fusions which are symptomatic or which may cause secondary instability or deformity. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle.
Wenzel Spine, Inc.
800-1135-00
In Commercial Distribution

  • 00813210021976 ()

  • Length: 35 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile
primaLOK FF 25mm Implant Assembly, Sterile The Wenzel Spine primaLOK FF Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is intended for use with or without bone graft, at a single or multiple levels from L1 to S1 inclusive. It is indicated for the posterior surgical treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the facets with instability, trauma (i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and pseudoarthrosis and failed fusions which are symptomatic or which may cause secondary instability or deformity. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle.
Wenzel Spine, Inc.
800-1125-00
In Commercial Distribution

  • 00813210021952 ()

  • Length: 25 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile
primaLOK FF 45mm Implant Assembly, Sterile The Wenzel Spine primaLOK FF Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is intended for use with or without bone graft, at a single or multiple levels from L1 to S1 inclusive. It is indicated for the posterior surgical treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the facets with instability, trauma (i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and pseudoarthrosis and failed fusions which are symptomatic or which may cause secondary instability or deformity. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle.
Wenzel Spine, Inc.
800-1145-00
In Commercial Distribution

  • 00813210021990 ()

  • Length: 45 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile
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