Company Name Brand Name GMDN Term 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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1 Level, 30mm 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-FD1-30
In Commercial Distribution

  • 111106130 ()
  • M364111106FD1300 ()


  • Spinal fixation plate, non-bioabsorbable
1 Level, 26mm 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-FD1-26
In Commercial Distribution

  • 111106126 ()
  • M364111106FD1260 ()


  • Spinal fixation plate, non-bioabsorbable
1 Level, 24mm 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-FD1-24
In Commercial Distribution

  • 111106124 ()
  • M364111106FD1240 ()


  • Spinal fixation plate, non-bioabsorbable
1 Level, 22mm 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-FD1-22
In Commercial Distribution

  • 111106122 ()
  • M364111106FD1220 ()


  • Spinal fixation plate, non-bioabsorbable
1 Level, 20mm 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-FD1-20
In Commercial Distribution

  • M364111106FD1200 ()
  • 111106120 ()


  • Spinal fixation plate, non-bioabsorbable
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
AlboSure Vascular Patch 1x 7.5 cm
LEMAITRE VASCULAR, INC.
AP10075T
In Commercial Distribution

  • 00840663104765 ()
AP10075T

  • Cardiovascular patch, animal-derived
AlboSure Vascular Patch 0.8x 7.5 cm
LEMAITRE VASCULAR, INC.
AP08075T
In Commercial Distribution

  • 00840663104604 ()
AP08075T

  • Cardiovascular patch, animal-derived
AlboSure Vascular Patch 0.6x 7.5 cm
LEMAITRE VASCULAR, INC.
AP06075T
In Commercial Distribution

  • 00840663104543 ()
AP06075T

  • Cardiovascular patch, animal-derived
Polypropylene
Innovasis, Inc.
LS-459
In Commercial Distribution

  • M711LS4590 ()
LS-459

  • Bone graft packing block
Hemashield Platinum Finesse Ultra-Thin Knitted Cardiovascular Patch
INTERVASCULAR SAS
M00202019561P0
In Commercial Distribution

  • 00384401017981 ()

  • Length: 15.2 Centimeter
  • Width: 2.5 Centimeter
M00202019561P0

  • Cardiovascular patch, animal-derived
Hemashield Platinum Finesse Ultra-Thin Knitted Cardiovascular Patch
INTERVASCULAR SAS
M00202019530P0
In Commercial Distribution

  • 00384401017974 ()

  • Length: 7.6 Centimeter
  • Width: 2.5 Centimeter
M00202019530P0

  • Cardiovascular patch, animal-derived
Hemashield Platinum Finesse Ultra-Thin Knitted Cardiovascular Patch
INTERVASCULAR SAS
M00202019585P0
In Commercial Distribution

  • 00384401017967 ()

  • Length: 15.2 Centimeter
  • Width: 0.8 Centimeter
M00202019585P0

  • Cardiovascular patch, animal-derived
Hemashield Platinum Finesse Ultra-Thin Knitted Cardiovascular Patch
INTERVASCULAR SAS
M00202019579P0
In Commercial Distribution

  • 00384401017950 ()

  • Length: 7.6 Centimeter
  • Width: 0.8 Centimeter
M00202019579P0

  • Cardiovascular patch, animal-derived
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