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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primaLOK FF 35mm Implant Assembly, Sterile The Wenzel Spine primaLOK FF Facet Fixation System is intended to stabilize the spine as an aid to fusion through bilateral immobilization of the facet joints. It is intended for use with or without bone graft, at a single or multiple levels from L1 to S1 inclusive. It is indicated for the posterior surgical treatment of any or all of the following: degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the facets with instability, trauma (i.e., fracture or dislocation), spondylolisthesis, spondylolysis, and pseudoarthrosis and failed fusions which are symptomatic or which may cause secondary instability or deformity. For transfacet fixation, the screws are inserted through the inferior articular process across the facet joint and into the pedicle. For translaminar facet fixation, the screws are inserted through the lateral aspect of the spinous process, through the lamina, through the inferior articular process, across the facet joint and into the pedicle.
WENZEL SPINE, INC.
800-1135-00
In Commercial Distribution

  • 00813210021976 ()

  • Length: 35 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile
microTargeting(TM) Electrode, backloaded, tungsten, nonsterile
FHC, INC.
MTBWBN(WH1)-00312
In Commercial Distribution

  • 10873263003128 ()
  • 00873263003121 ()

  • Length: 305 Millimeter
  • Impedance: Megaohms
  • Length: 35 Millimeter
  • Outer Diameter: 0.34 Millimeter
MTBWBN(WH1)

  • Depth electrode
microTargeting(TM) Electrode, Back loaded, Platinum/Iridium with Glass Insulation
FHC, INC.
MTBPBN(AZ1)-00291
In Commercial Distribution

  • 10873263002916 ()
  • 00873263002919 ()

  • Outer Diameter: 0.63 Millimeter
  • Length: 35 Millimeter
  • Impedance: Megaohms
  • Length: 260 Millimeter
MTBPBN(AZ1)

  • Depth electrode
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
SET OF 10 ANCHOR BOLTS, LENGTH 35MM, ACCESSORY OF MICRODEEP DEPTH ELECTRODE
DIXI MEDICAL
ANCHOR BOLT
In Commercial Distribution

  • 03664539000695 ()
  • 03664539003313 ()

  • Length: 35 Millimeter
ACS-035SMS-10

  • Depth electrode
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
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
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
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
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
HGK12/75CPUT (1)
In Commercial Distribution

  • 00384401014935 ()

  • Width: 12 Millimeter
  • Length: 75 Millimeter
HGK12/75CPUT (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
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
HGK12/75CP (1)
In Commercial Distribution

  • 00384401014904 ()

  • Width: 12 Millimeter
  • Length: 75 Millimeter
HGK12/75CP (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
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
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
HEK08/75CPUT (1)
In Commercial Distribution

  • 00384401001478 ()

  • Width: 8 Millimeter
  • Length: 75 Millimeter
HEK08/75CPUT (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
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
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
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
HEK06/75CP (1)
In Commercial Distribution

  • 00384401001423 ()

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