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 45mm 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.
800-1145-00
In Commercial Distribution

  • 00813210021990 ()

  • Length: 45 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile
microTargeting(TM) Electrode, shielded, tungsten, nonsterile, 6x
FHC, INC.
MTSWBN(LX1)-00488
In Commercial Distribution

  • 10873263004880 ()
  • 00873263004883 ()

  • Outer Diameter: 1.24 Millimeter
  • Impedance: Megaohms
  • Length: 50 Millimeter
  • Length: 193 Millimeter
  • Length: 49 Millimeter
  • Length: 246 Millimeter
MTSWBN(LX1)

  • Depth electrode
microTargeting(TM) Electrode, shielded, platinum, DZAP(L), nonsterile, 6x
FHC, INC.
MTSPLN(RD1)-00486
In Commercial Distribution

  • 10873263004866 ()
  • 00873263004869 ()

  • Length: 216 Millimeter
  • Length: 163 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 1.24 Millimeter
  • Length: 50 Millimeter
  • Length: 49 Millimeter
MTSPLN(RD1)

  • Depth electrode
microTargeting(TM) Electrode, shielded, platinum, non-sterile, 6x
FHC, INC.
MTSPBN(LX1)-00482
In Commercial Distribution

  • 10873263004828 ()
  • 00873263004821 ()

  • Length: 193 Millimeter
  • Length: 50 Millimeter
  • Impedance: Megaohms
  • Outer Diameter: 1.24 Millimeter
  • Length: 49 Millimeter
  • Length: 246 Millimeter
MTSPBN(LX1)

  • Depth electrode
microTargeting(TM) Electrode, shielded, platinum, nonsterile, 6x
FHC, INC.
MTSPAN(RD1)-00475
In Commercial Distribution

  • 10873263004750 ()
  • 00873263004753 ()

  • Length: 163 Millimeter
  • Impedance: Megaohms
  • Length: 49 Millimeter
  • Length: 216 Millimeter
  • Length: 50 Millimeter
  • Outer Diameter: 1.245 Millimeter
MTSPAN(RD1)

  • Depth electrode
microTargeting(TM) Electrode, back loaded, non sterile, Platinum/Iridium, glass insulated
FHC, INC.
MTBPBN(EN2)-00297
In Commercial Distribution

  • 10873263002978 ()
  • 00873263002971 ()

  • Outer Diameter: 0.63 Millimeter
  • Length: 50 Millimeter
  • Length: 300 Millimeter
  • Impedance: Megaohms
MTBPBN(EN2)

  • 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
Hemapatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK50/50P (1)
In Commercial Distribution

  • 00384401001577 ()

  • Length: 50 Millimeter
  • Width: 50 Millimeter
HEK50/50P (1)

  • Cardiovascular patch, animal-derived
Hemapatch Knitted Collagen Coated Vascular Patch
INTERVASCULAR SAS
HEK25/50P (1)
In Commercial Distribution

  • 00384401001560 ()

  • Length: 50 Millimeter
  • Width: 25 Millimeter
HEK25/50P (1)

  • Cardiovascular patch, animal-derived
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