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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SPSTI-5 - EvaQMaxPen, Smoke Pencil, Telescopic, Button, Holster, Insulated Blade, 5 meter Hose- Each, elbow type
MEDIMAX TECH INC.
SPSTI-5
In Commercial Distribution

  • 10817325023440 ()
  • 00817325023443 ()
  • 20817325023447 ()
  • 30817325023444 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
SPSTI - EvaQMaxPen, Smoke Pencil, Telescopic, Button, Holster, Insulated Blade, 3 Meter Hose - Each; elbow type
MEDIMAX TECH INC.
SPSTI
In Commercial Distribution

  • 20817325023430 ()
  • 10817325023433 ()
  • 00817325023436 ()
  • 30817325023437 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
SPST-5 - EvaQMaxPen, Smoke Pencil, Telescopic, Button, Holster, Non-Stick Blade, 5 meter Hose - Each ; elbow type
MEDIMAX TECH INC.
SPST-5
In Commercial Distribution

  • 20817325023423 ()
  • 10817325023426 ()
  • 00817325023429 ()
  • 30817325023420 ()


  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
  • Surgical plume evacuation system
SPST - EvaQMaxPen, Smoke Pencil, Telescopic, Button, Holster, Non-Stick Blade, 3 Meter (10') Hose ; Elbow type
MEDIMAX TECH INC.
SPST
In Commercial Distribution

  • 20817325023416 ()
  • 10817325023419 ()
  • 00817325023412 ()
  • 30817325023413 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
EvBNHDE- Double extension, telescopic, Smoke Evacuation Pencil with non-stick electrode and holster 1 pc per pack/ 10 pcs per box/ 8 boxes per case.
MEDIMAX TECH INC.
EvBNHDE- Double extension, telescopic, Smoke Evacuation Pencil with Non-Stick
In Commercial Distribution

  • 20817325023409 ()
  • 10817325023402 ()
  • 00817325023405 ()


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

  • 20817325023089 ()
  • 10817325023082 ()
  • 00817325023085 ()


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

  • 20817325023072 ()
  • 10817325023075 ()
  • 00817325023078 ()


  • Surgical plume evacuation system
  • Electrosurgical return electrode, single-use
EcoEvRNH-15 Standard Smoke Evacuation Pencil with 2.5"Ceramic Coated Non Stick Blade with Holster; 15' Cable - Single Pack
MEDIMAX TECH INC.
EcoEvRNH-15
In Commercial Distribution

  • 20817325023065 ()
  • 10817325023068 ()
  • 00817325023061 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
Standard Smoke Evacuation Pencil with 2.5"Ceramic Coated Non Stick Blade with Holster
MEDIMAX TECH INC.
EcoEvRNH-10
In Commercial Distribution

  • 20817325023058 ()
  • 10817325023051 ()
  • 00817325023054 ()


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

  • 20817325023041 ()
  • 10817325023044 ()
  • 00817325023047 ()


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

  • 20817325023034 ()
  • 10817325023037 ()
  • 00817325023030 ()


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

  • 20817325023027 ()
  • 10817325023020 ()
  • 00817325023023 ()


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

  • 20817325023010 ()
  • 10817325023013 ()
  • 00817325023016 ()


  • Surgical plume evacuation system
  • Open-surgery electrosurgical handpiece/electrode, monopolar, reusable
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
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
10mm 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-FD2
In Commercial Distribution

  • 1199022 ()
  • M364119902FD20 ()

  • Outer Diameter: 10 Millimeter
  • Length: 25 Millimeter


  • Metallic spinal interbody fusion cage
18mm 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-FD10
In Commercial Distribution

  • 11990210 ()
  • M364119902FD100 ()

  • Outer Diameter: 18 Millimeter
  • Length: 25 Millimeter


  • Metallic spinal interbody fusion cage
10mm 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-FD1
In Commercial Distribution

  • M364119902FD10 ()
  • 1199021 ()

  • Length: 21 Millimeter
  • Outer Diameter: 10 Millimeter


  • Metallic spinal interbody fusion cage
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
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