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 Class Implantable

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Urinary prosthesis, female, non-surgical
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003027 ()

  • Length: 30 Millimeter
  • Length: 35 Millimeter
  • Length: 40 Millimeter
  • Length: 45 Millimeter
  • Length: 50 Millimeter
  • Length: 55 Millimeter
  • Length: 60 Millimeter
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=man203511

  • Intraurethral valve/pump
Urinary prosthesis, female, non-surgical
VESIFLO INC
Sep 2016
Not in Commercial Distribution

  • 08625630003002 ()

  • Length: 60 Millimeter
  • Length: 55 Millimeter
  • Length: 50 Millimeter
  • Length: 45 Millimeter
  • Length: 40 Millimeter
  • Length: 35 Millimeter
  • Length: 30 Millimeter
203511

  • Intraurethral valve/pump
Hemapatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK75/75P (1)
In Commercial Distribution

  • 00384401001515 ()

  • Length: 75 Millimeter
  • Width: 75 Millimeter
HEK75/75P (1)

  • Cardiovascular patch, animal-derived
Hemagard Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK25/75P (1)
In Commercial Distribution

  • 00384401015024 ()

  • Width: 25 Millimeter
  • Length: 75 Millimeter
HGK25/75P (1)

  • Cardiovascular patch, animal-derived
Hemagard Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK50/75P (1)
In Commercial Distribution

  • 00384401015123 ()

  • Width: 50 Millimeter
  • Length: 75 Millimeter
HGK50/75P (1)

  • Cardiovascular patch, animal-derived
Hemagard Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK75/75P (1)
In Commercial Distribution

  • 00384401014850 ()

  • Width: 75 Millimeter
  • Length: 75 Millimeter
HGK75/75P (1)

  • Cardiovascular patch, animal-derived
Hemagard Carotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGKTP08/75CPUT (1)
In Commercial Distribution

  • 00384401015208 ()

  • Width: 8 Millimeter
  • Length: 75 Millimeter
HGKTP08/75CPUT (1)

  • Cardiovascular patch, animal-derived
Hemagard Carotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGKTP06/75CPUT (1)
In Commercial Distribution

  • 00384401015192 ()

  • Width: 6 Millimeter
  • Length: 75 Millimeter
HGKTP06/75CPUT (1)

  • Cardiovascular patch, animal-derived
Hemagard Carotid Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGKTP08/75CP (1)
In Commercial Distribution

  • 00384401015185 ()

  • Width: 8 Millimeter
  • Length: 75 Millimeter
HGKTP08/75CP (1)

  • Cardiovascular patch, animal-derived
Hemagard Carotid Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGKTP06/75CP (1)
In Commercial Distribution

  • 00384401015178 ()

  • Width: 6 Millimeter
  • Length: 75 Millimeter
HGKTP06/75CP (1)

  • Cardiovascular patch, animal-derived
Hemagard Carotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK25/75CPUT (1)
In Commercial Distribution

  • 00384401015147 ()

  • Width: 25 Millimeter
  • Length: 75 Millimeter
HGK25/75CPUT (1)

  • Cardiovascular patch, animal-derived
Hemagard Carotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK12/75CPUT (1)
In Commercial Distribution

  • 00384401014935 ()

  • Width: 12 Millimeter
  • Length: 75 Millimeter
HGK12/75CPUT (1)

  • Cardiovascular patch, animal-derived
Hemagard Carotid Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK14/75CP (1)
In Commercial Distribution

  • 00384401014911 ()

  • Width: 14 Millimeter
  • Length: 75 Millimeter
HGK14/75CP (1)

  • Cardiovascular patch, animal-derived
Hemagard Carotid Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK10/75CP (1)
In Commercial Distribution

  • 00384401014898 ()

  • Width: 10 Millimeter
  • Length: 75 Millimeter
HGK10/75CP (1)

  • Cardiovascular patch, animal-derived
Hemagard Carotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK14/75CPUT (1)
In Commercial Distribution

  • 00384401014942 ()

  • Width: 14 Millimeter
  • Length: 75 Millimeter
HGK14/75CPUT (1)

  • Cardiovascular patch, animal-derived
Hemagard Carotid Patch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK10/75CPUT (1)
In Commercial Distribution

  • 00384401014928 ()

  • Width: 10 Millimeter
  • Length: 75 Millimeter
HGK10/75CPUT (1)

  • Cardiovascular patch, animal-derived
Hemagard Carotid Patch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HGK12/75CP (1)
In Commercial Distribution

  • 00384401014904 ()

  • Width: 12 Millimeter
  • Length: 75 Millimeter
HGK12/75CP (1)

  • Cardiovascular patch, animal-derived
Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK12/75CPUT (1)
In Commercial Distribution

  • 00384401001492 ()

  • Width: 12 Millimeter
  • Length: 75 Millimeter
HEK12/75CPUT (1)

  • Cardiovascular patch, animal-derived
Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK08/75CPUT (1)
In Commercial Distribution

  • 00384401001478 ()

  • Width: 8 Millimeter
  • Length: 75 Millimeter
HEK08/75CPUT (1)

  • Cardiovascular patch, animal-derived
Hemacarotidpatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK14/75CP (1)
In Commercial Distribution

  • 00384401001454 ()

  • Length: 75 Millimeter
  • Width: 14 Millimeter
HEK14/75CP (1)

  • Cardiovascular patch, animal-derived
Hemacarotidpatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK10/75CP (1)
In Commercial Distribution

  • 00384401001430 ()

  • Length: 75 Millimeter
  • Width: 10 Millimeter
HEK10/75CP (1)

  • Cardiovascular patch, animal-derived
Hemacarotidpatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK08/75CP (1)
In Commercial Distribution

  • 00384401001416 ()

  • Length: 75 Millimeter
  • Width: 8 Millimeter
HEK08/75CP (1)

  • Cardiovascular patch, animal-derived
Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK10/75CPUT (1)
In Commercial Distribution

  • 00384401001485 ()

  • Width: 10 Millimeter
  • Length: 75 Millimeter
HEK10/75CPUT (1)

  • Cardiovascular patch, animal-derived
Hemacarotidpatch Knitted Ultrathin Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK06/75CPUT (1)
In Commercial Distribution

  • 00384401001461 ()

  • Width: 6 Millimeter
  • Length: 75 Millimeter
HEK06/75CPUT (1)

  • Cardiovascular patch, animal-derived
Hemacarotidpatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK12/75CP (1)
In Commercial Distribution

  • 00384401001447 ()

  • Length: 75 Millimeter
  • Width: 12 Millimeter
HEK12/75CP (1)

  • Cardiovascular patch, animal-derived
Hemacarotidpatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK06/75CP (1)
In Commercial Distribution

  • 00384401001423 ()

  • Length: 75 Millimeter
  • Width: 6 Millimeter
HEK06/75CP (1)

  • Cardiovascular patch, animal-derived
PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X80mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDR-850-080
In Commercial Distribution

  • 00814008029525 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 80 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X70mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDR-850-070
In Commercial Distribution

  • 00814008029501 ()

  • Outer Diameter: 8.5 Millimeter
  • Length: 70 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X65mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDR-850-065
In Commercial Distribution

  • 00814008029495 ()

  • Length: 65 Millimeter
  • Outer Diameter: 8.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X55mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PDR-850-055
In Commercial Distribution

  • 00814008029471 ()

  • Length: 55 Millimeter
  • Outer Diameter: 8.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
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