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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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
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
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
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 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
XenoSure Biologic Patch, 12cm x 25cm
Lemaitre Vascular, Inc.
12P25
In Commercial Distribution

  • 00840663108718 ()
12P25

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 5cm x 10cm
Lemaitre Vascular, Inc.
5P10
In Commercial Distribution

  • 00840663108701 ()
5P10

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

  • 00840663108695 ()
2.5P15

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 1.5cm x 10cm, eIFU
Lemaitre Vascular, Inc.
e1.5P10
In Commercial Distribution

  • 00840663107414 ()
e1.5P10

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 6cm x 8cm, eIFU
Lemaitre Vascular, Inc.
e6P8
In Commercial Distribution

  • 00840663106806 ()
e6P8

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 0.6cmx8cm
Lemaitre Vascular, Inc.
0.6BV8
In Commercial Distribution

  • 00840663106745 ()


  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 1cm x 14cm, eIFU
Lemaitre Vascular, Inc.
e1P14
In Commercial Distribution

  • 00840663106356 ()
e1P14

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 10cm x 16cm, eIFU
Lemaitre Vascular, Inc.
e10P16
In Commercial Distribution

  • 00840663106349 ()
e10P16

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 8cm x 14cm, eIFU
Lemaitre Vascular, Inc.
e8P14
In Commercial Distribution

  • 00840663106332 ()
e8P14

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 4cm x 6cm, eIFU
Lemaitre Vascular, Inc.
e4P6
In Commercial Distribution

  • 00840663106325 ()
e4P6

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 4cm x 4cm, eIFU
Lemaitre Vascular, Inc.
e4P4
In Commercial Distribution

  • 00840663106318 ()
e4P4

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 2cm x 9cm, eIFU
Lemaitre Vascular, Inc.
e2P9
In Commercial Distribution

  • 00840663106301 ()
e2P9

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 0.8cm x 8cm, eIFU
Lemaitre Vascular, Inc.
e0.8P8
In Commercial Distribution

  • 00840663106295 ()
e0.8P8

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 1cm x 6cm
Lemaitre Vascular, Inc.
e1P6
In Commercial Distribution

  • 00840663106288 ()
e1P6

  • Cardiovascular patch, animal-derived
XenoSure Biologic Patch, 1cmx10cm
Lemaitre Vascular, Inc.
1BV10
In Commercial Distribution

  • 00840663106097 ()


  • Cardiovascular patch, animal-derived
AlboSure Vascular Patch 2x9 cm
Lemaitre Vascular, Inc.
AP20090R
In Commercial Distribution

  • 00840663105021 ()
AP20090R

  • Cardiovascular patch, animal-derived
AlboSure Vascular Patch 1x 15 cm
Lemaitre Vascular, Inc.
AP10150R
In Commercial Distribution

  • 00840663104895 ()
AP10150R

  • Cardiovascular patch, animal-derived
AlboSure Vascular Patch 1x 10 cm
Lemaitre Vascular, Inc.
AP10100R
In Commercial Distribution

  • 00840663104802 ()
AP10100R

  • Cardiovascular patch, animal-derived
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