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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EvBNHT-15 Telescopic Smoke Evacuation Pencil with Insulated 2.5" Ceramic Coated Non Stick Blade with Holster; 15' Cable - Single Pack
MEDIMAX TECH INC.
EvBNHT-15
In Commercial Distribution

  • 20817325023003 ()
  • 10817325023006 ()
  • 00817325023009 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EvBNHT-10 Telescopic Smoke Evacuation Pencil with Insulated 2.5" Ceramic Coated Non Stick Blade with Holster; 10' Cable - Single Pack
MEDIMAX TECH INC.
EvBNHT-10
In Commercial Distribution

  • 20817325022990 ()
  • 10817325022993 ()
  • 00817325022996 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EvBNH-15 Telescopic Smoke Evacuation Pencil with 2.5" Ceramic Coated Non Stick Blade with Holster; 15' Cable - Single Pack
MEDIMAX TECH INC.
EvBNH-15
In Commercial Distribution

  • 20817325022983 ()
  • 10817325022986 ()
  • 00817325022989 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EvBNH-10 Telescopic Smoke Evacuation Pencil with 2.5" Ceramic Coated Non Stick Blade with Holster; 10' Cable - Single Pack
MEDIMAX TECH INC.
EvBNH-10
In Commercial Distribution

  • 20817325022976 ()
  • 10817325022979 ()
  • 00817325022972 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EvBNH Push Button ESU Smoke Pencil - 2.5'' Stainless & Coated Blade, Holster, ESU Smoke Pencil, 10'' Cable
MEDIMAX TECH INC.
EvBNH Push Button ESU Smoke Pencil
In Commercial Distribution

  • 20817325020767 ()
  • 10817325020760 ()
  • 00817325020763 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EvBH Push Button ESU Pencil - 2.5'' Stainless Blade, Holster, ESU Pencil, 10'' Cable
MEDIMAX TECH INC.
EvBH Push Button ESU Pencil
In Commercial Distribution

  • 00817325020756 ()
  • 10817325020753 ()
  • 20817325020750 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EvBN Push Button ESU Pencil - 2.5'' Stainless & Coated Blade, No Holster, ESU Pencil, 10'' Cable
MEDIMAX TECH INC.
EvBN Push Button ESU Pencil
In Commercial Distribution

  • 20817325020743 ()
  • 10817325020746 ()
  • 00817325020749 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EvB Push Button ESU Pencil - 2.5'' Stainless Blade, No Holster, Smoke Pencil, 10'' Cable
MEDIMAX TECH INC.
EvB Push Button ESU Pencil
In Commercial Distribution

  • 20817325020736 ()
  • 10817325020739 ()
  • 00817325020732 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
EXTLI-5 : Extendable Smoke Evacuation Pencil, Insulated Non-stick Ceramic Coated Blade, Holster, 15' Hose (1pc)
Medisourcenet, Inc
EXTLI-5
In Commercial Distribution

  • 10850034735112 ()
  • 00850034735115 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
EXTL-5 : Extendable Smoke Evacuation Pencil, Non-stick Ceramic Coated Blade, Holster, 15' Hose (1pc)
Medisourcenet, Inc
EXTL-5
In Commercial Distribution

  • 10850034735105 ()
  • 00850034735108 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
EXTLI - Extendable Smoke Evacuation Pencil, Insulated Non-stick Ceramic Coated Blade, Holster, 10' Hose (1pc)
Medisourcenet, Inc
EXTLI
In Commercial Distribution

  • 10850034735099 ()
  • 00850034735092 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
EXTL - Extendable Smoke Evacuation Pencil, Non-stick Ceramic Coated Blade, Holster, 10' Hose (1pc)
Medisourcenet, Inc
EXTL
In Commercial Distribution

  • 10850034735082 ()
  • 00850034735085 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
REGL-5 : Regular Non-Extendable Smoke Evacuation Pencil, Non-stick Ceramic Coated Blade, Holster, 15' Hose (1pc)
Medisourcenet, Inc
REGL-5
In Commercial Distribution

  • 10850034735075 ()
  • 00850034735078 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
REGLI-5 : Regular Non-Extendable Smoke Evacuation Pencil, Insulated Non-stick Ceramic Coated Blade, Holster, 15' Hose (1pc)
Medisourcenet, Inc
REGLI-5
In Commercial Distribution

  • 10850034735068 ()
  • 00850034735061 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
REGLI - Regular Non-Extendable Smoke Evacuation Pencil, Insulated Non-stick Ceramic Coated Blade, Holster, 10' Hose (1pc)
Medisourcenet, Inc
REGLI
In Commercial Distribution

  • 10850034735051 ()
  • 00850034735054 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
REGL - Regular Non-Extendable Smoke Evacuation Pencil, Non-stick Ceramic Coated Blade, Holster, 10' Hose (1pc)
Medisourcenet, Inc
REGL
In Commercial Distribution

  • 10850034735044 ()
  • 00850034735047 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
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 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
18mm x 21mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.
MEDICAL DESIGNS LLC
11-9902-FD9
In Commercial Distribution

  • 1199029 ()
  • M364119902FD90 ()

  • Outer Diameter: 18 Millimeter
  • Length: 21 Millimeter


  • Metallic spinal interbody fusion cage
16mm x 25mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.
MEDICAL DESIGNS LLC
11-9902-FD8
In Commercial Distribution

  • 1199028 ()
  • M364119902FD80 ()

  • Outer Diameter: 16 Millimeter
  • Length: 25 Millimeter


  • Metallic spinal interbody fusion cage
16mm x 21mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.
MEDICAL DESIGNS LLC
11-9902-FD7
In Commercial Distribution

  • M364119902FD70 ()


  • Metallic spinal interbody fusion cage
14mm x 25mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.
MEDICAL DESIGNS LLC
11-9902-FD6
In Commercial Distribution

  • 1199026 ()
  • M364119902FD60 ()

  • Outer Diameter: 14 Millimeter
  • Length: 25 Millimeter


  • Metallic spinal interbody fusion cage
14mm x 21mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.
MEDICAL DESIGNS LLC
11-9902-FD5
In Commercial Distribution

  • 1199025 ()
  • M364119902FD50 ()

  • Outer Diameter: 14 Millimeter
  • Length: 21 Millimeter


  • Metallic spinal interbody fusion cage
12mm x 25mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.
MEDICAL DESIGNS LLC
11-9902-FD4
In Commercial Distribution

  • 1199024 ()
  • M364119902FD40 ()

  • Outer Diameter: 12 Millimeter
  • Length: 25 Millimeter


  • Metallic spinal interbody fusion cage
12mm x 21mm Cage; The Asfora Bullet Cage® is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.
MEDICAL DESIGNS LLC
11-9902-FD3
In Commercial Distribution

  • 1199023 ()
  • M364119902FD30 ()

  • Outer Diameter: 12 Millimeter
  • Length: 21 Millimeter


  • Metallic spinal interbody fusion cage
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