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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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Asfora Anterior Cervical Plate System - M364111106FD3690

3 Level, 69mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
MEDICAL DESIGNS LLC
11-1106-FD3-69
In Commercial Distribution

  • 111106369 ()
  • M364111106FD3690 ()


  • Spinal fixation plate, non-bioabsorbable

Asfora Anterior Cervical Plate System - M364111106FD3660

3 Level, 66mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
MEDICAL DESIGNS LLC
11-1106-FD3-66
In Commercial Distribution

  • 111106366 ()
  • M364111106FD3660 ()


  • Spinal fixation plate, non-bioabsorbable

Asfora Anterior Cervical Plate System - M364111106FD3630

3 Level, 63mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
MEDICAL DESIGNS LLC
11-1106-FD3-63
In Commercial Distribution

  • 111106363 ()
  • M364111106FD3630 ()


  • Spinal fixation plate, non-bioabsorbable

Asfora Anterior Cervical Plate System - M364111106FD3600

3 Level, 60mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
MEDICAL DESIGNS LLC
11-1106-FD3-60
In Commercial Distribution

  • 111106360 ()
  • M364111106FD3600 ()


  • Spinal fixation plate, non-bioabsorbable

Asfora Anterior Cervical Plate System - M364111106FD3570

3 Level, 57mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
MEDICAL DESIGNS LLC
11-1106-FD3-57
In Commercial Distribution

  • 111106357 ()
  • M364111106FD3570 ()


  • Spinal fixation plate, non-bioabsorbable

Asfora Anterior Cervical Plate System - M364111106FD3540

3 Level, 54mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
MEDICAL DESIGNS LLC
11-1106-FD3-54
In Commercial Distribution

  • 111106354 ()
  • M364111106FD3540 ()


  • Spinal fixation plate, non-bioabsorbable

Asfora Anterior Cervical Plate System - M364111106FD3510

3 Level, 51mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
MEDICAL DESIGNS LLC
11-1106-FD3-51
In Commercial Distribution

  • 111106351 ()
  • M364111106FD3510 ()


  • Spinal fixation plate, non-bioabsorbable

Asfora Anterior Cervical Plate System - M364111106FD2350

2 Level, 35mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
MEDICAL DESIGNS LLC
11-1106-FD2-35
In Commercial Distribution

  • 111106235 ()
  • M364111106FD2350 ()


  • Spinal fixation plate, non-bioabsorbable

XenoSure Biologic Pledgets - 00840663109357

XenoSure Biologic Pledgets, 0.5cm x 1.0cm
Lemaitre Vascular, Inc.
PL0510R25
In Commercial Distribution

  • 00840663109357 ()
PL0510R25

  • Cardiovascular patch, animal-derived

XenoSure Biologic Pledgets - 00840663109340

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 - 00840663109333

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 - 00840663109227

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 - 00840663109210

XenoSure Thick Biologic Patch, 6 x 8cm - eP
Lemaitre Vascular, Inc.
e6P8T
In Commercial Distribution

  • 00840663109210 ()
e6P8T

  • Cardiovascular patch, animal-derived

XenoSure Biologic Patch - 00840663108831

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 - 00840663108824

XenoSure Biologic Patch, 5cm x 10cm, eIFU
Lemaitre Vascular, Inc.
e5P10
In Commercial Distribution

  • 00840663108824 ()
e5P10

  • Cardiovascular patch, animal-derived

XenoSure Biologic Patch - 00840663108800

XenoSure Biologic Patch, 12cm x 25cm
Lemaitre Vascular, Inc.
12BV25
In Commercial Distribution

  • 00840663108800 ()
12BV25

  • Cardiovascular patch, animal-derived

XenoSure Biologic Patch - 00840663108794

XenoSure Biologic Patch, 5cm x 10cm
Lemaitre Vascular, Inc.
5BV10
In Commercial Distribution

  • 00840663108794 ()
5BV10

  • Cardiovascular patch, animal-derived

XenoSure Biologic Patch - 00840663108787

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 - 00840663108718

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

  • 00840663108718 ()
12P25

  • Cardiovascular patch, animal-derived

XenoSure Biologic Patch - 00840663108701

XenoSure Biologic Patch, 5cm x 10cm
Lemaitre Vascular, Inc.
5P10
In Commercial Distribution

  • 00840663108701 ()
5P10

  • Cardiovascular patch, animal-derived

XenoSure Biologic Patch - 00840663108695

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 - 00840663107414

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 - 00840663106806

XenoSure Biologic Patch, 6cm x 8cm, eIFU
Lemaitre Vascular, Inc.
e6P8
In Commercial Distribution

  • 00840663106806 ()
e6P8

  • Cardiovascular patch, animal-derived

XenoSure Biologic Patch - 00840663106745

XenoSure Biologic Patch, 0.6cmx8cm
Lemaitre Vascular, Inc.
0.6BV8
In Commercial Distribution

  • 00840663106745 ()


  • Cardiovascular patch, animal-derived

XenoSure Biologic Patch - 00840663106356

XenoSure Biologic Patch, 1cm x 14cm, eIFU
Lemaitre Vascular, Inc.
e1P14
In Commercial Distribution

  • 00840663106356 ()
e1P14

  • Cardiovascular patch, animal-derived

XenoSure Biologic Patch - 00840663106349

XenoSure Biologic Patch, 10cm x 16cm, eIFU
Lemaitre Vascular, Inc.
e10P16
In Commercial Distribution

  • 00840663106349 ()
e10P16

  • Cardiovascular patch, animal-derived

XenoSure Biologic Patch - 00840663106332

XenoSure Biologic Patch, 8cm x 14cm, eIFU
Lemaitre Vascular, Inc.
e8P14
In Commercial Distribution

  • 00840663106332 ()
e8P14

  • Cardiovascular patch, animal-derived

XenoSure Biologic Patch - 00840663106325

XenoSure Biologic Patch, 4cm x 6cm, eIFU
Lemaitre Vascular, Inc.
e4P6
In Commercial Distribution

  • 00840663106325 ()
e4P6

  • Cardiovascular patch, animal-derived

XenoSure Biologic Patch - 00840663106318

XenoSure Biologic Patch, 4cm x 4cm, eIFU
Lemaitre Vascular, Inc.
e4P4
In Commercial Distribution

  • 00840663106318 ()
e4P4

  • Cardiovascular patch, animal-derived

XenoSure Biologic Patch - 00840663106301

XenoSure Biologic Patch, 2cm x 9cm, eIFU
Lemaitre Vascular, Inc.
e2P9
In Commercial Distribution

  • 00840663106301 ()
e2P9

  • Cardiovascular patch, animal-derived
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