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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sEEG Depthalon Electrode, 16 macro contacts mini connector, 1 exit, 1, lead, 1 tail
PMT CORPORATION
2102-16-166
In Commercial Distribution

  • 00650551147343 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 14 MACRO CONTACTS, MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-14-149
In Commercial Distribution

  • 00650551147657 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 12 MACRO CONTACTS, MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-12-149
In Commercial Distribution

  • 00650551147640 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, NON-STANDARD MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-16-173
In Commercial Distribution

  • 00650551147411 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, NON-STANDARD MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-16-172
In Commercial Distribution

  • 00650551147404 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, NON-STANDARD MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-16-171
In Commercial Distribution

  • 00650551147398 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, NON-STANDARD MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-16-170
In Commercial Distribution

  • 00650551147381 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, NON-STANDARD MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-16-169
In Commercial Distribution

  • 00650551147374 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, NON-STANDARD MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-16-168
In Commercial Distribution

  • 00650551147367 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, NON-STANDARD MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-16-167
In Commercial Distribution

  • 00650551147350 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, NON-STANDARD MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-16-165
In Commercial Distribution

  • 00650551147336 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, NON-STANDARD MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-16-164
In Commercial Distribution

  • 00650551147329 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, NON-STANDARD MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-16-163
In Commercial Distribution

  • 00650551147312 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, NON-STANDARD MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-16-162
In Commercial Distribution

  • 00650551147305 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, NON-STANDARD MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-16-161
In Commercial Distribution

  • 00650551147299 ()


  • Depth electrode
PLATINUM sEEG DEPTH ELECTRODE, 16 MACRO CONTACTS, NON-STANDARD MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL
PMT CORPORATION
2102-16-160
In Commercial Distribution

  • 00650551147282 ()


  • Depth electrode
primaLOK SP 28mm Medium Boxless Implant, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0828-00
In Commercial Distribution

  • 00813210021785 ()

  • Width: 28 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
primaLOK SP 18mm Implant Assembly, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0118-00
In Commercial Distribution

  • 00813210021778 ()

  • Height: 18 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
primaLOK SP 15mm Implant Assembly, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as ack pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0115-00
In Commercial Distribution

  • 00813210021761 ()

  • Height: 15 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
primaLOK SP 12mm Implant Assembly, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as ack pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0112-00
In Commercial Distribution

  • 00813210021754 ()

  • Height: 12 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
primaLOK SP 10mm Implant Assembly, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as ack pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0110-00
In Commercial Distribution

  • 00813210021747 ()

  • Height: 10 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
primaLOK SP 8mm Implant Assembly, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0108-00
In Commercial Distribution

  • 00813210021730 ()

  • Height: 8 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
primaLOK SP 6mm Implant Assembly, Sterile The Wenzel Spine primaLOK SP Interspinous Fusion System is a posterior, nonpedicle supplemental fixation device, intended for use in the non-cervical spine (T1-S1). it is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), and/or tumor. The primaLOK SP Interspinous Fusion System is intended for use at one level with bone graft material and not intended for stand-alone use.
Wenzel Spine, Inc.
800-0106-00
In Commercial Distribution

  • 00813210021723 ()

  • Height: 6 Millimeter


  • Orthopaedic fixation plate kit, non-bioabsorbable, non-antimicrobial
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
primaLOK FF 40mm 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.
800-1140-00
In Commercial Distribution

  • 00813210021983 ()

  • Length: 40 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile
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 30mm 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.
800-1130-00
In Commercial Distribution

  • 00813210021969 ()

  • Length: 30 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
Zip Pen Extension Nozzle 5.2" (13.2 cm)
MEGADYNE MEDICAL PRODUCTS, INC.
2560J
In Commercial Distribution

  • 10614559105757 ()
  • 50614559105755 ()
  • 30614559105751 ()
2560J

  • Surgical plume evacuation system
Zip Pen Extension Nozzle 2.7" (6.8 cm)
MEGADYNE MEDICAL PRODUCTS, INC.
2540J
In Commercial Distribution

  • 10614559105320 ()
  • 30614559105324 ()
  • 50614559105328 ()
2540J

  • Surgical plume evacuation system
XenoSure Thick Biologic Patch, 10 x 16cm - eP
Lemaitre Vascular, Inc.
e10P16T
In Commercial Distribution

  • 00840663109227 ()
e10P16T

  • Cardiovascular patch, animal-derived
XenoSure Thick Biologic Patch, 6 x 8cm - eP
Lemaitre Vascular, Inc.
e6P8T
In Commercial Distribution

  • 00840663109210 ()
e6P8T

  • Cardiovascular patch, animal-derived
XenoSure Biologic Pledgets, 0.5cm x 1.0cm
Lemaitre Vascular, Inc.
PL0510R25
In Commercial Distribution

  • 00840663109357 ()
PL0510R25

  • Cardiovascular patch, animal-derived
XenoSure Biologic Pledgets, 0.5cm x 0.6cm, 25-Count
Lemaitre Vascular, Inc.
PL0506R25
In Commercial Distribution

  • 00840663109340 ()
PL0506R25

  • Cardiovascular patch, animal-derived
XenoSure Biologic Pledgets, 0.3cm x 0.7cm
Lemaitre Vascular, Inc.
PL0307R25
In Commercial Distribution

  • 00840663109333 ()
PL0307R25

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 2.5cm x 15cm, eIFU
Lemaitre Vascular, Inc.
e2.5P15
In Commercial Distribution

  • 00840663108831 ()
e2.5P15

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 5cm x 10cm, eIFU
Lemaitre Vascular, Inc.
e5P10
In Commercial Distribution

  • 00840663108824 ()
e5P10

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 12cm x 25cm
Lemaitre Vascular, Inc.
12BV25
In Commercial Distribution

  • 00840663108800 ()
12BV25

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 5cm x 10cm
Lemaitre Vascular, Inc.
5BV10
In Commercial Distribution

  • 00840663108794 ()
5BV10

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 2.5cm x 15cm
Lemaitre Vascular, Inc.
2.5BV15
In Commercial Distribution

  • 00840663108787 ()
2.5BV15

  • Cardiovascular patch, animal-derived
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