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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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primaLOK FF 25mm 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.
800-1125-00
In Commercial Distribution

  • 00813210021952 ()

  • Length: 25 Millimeter


  • Orthopaedic bone screw, non-bioabsorbable, sterile
DACRIOS Variety Pack Collagen (Temporary) Punctal Plug 0.2mm, 0.3mm, & 0.4mm X 2mm , Box of 12
Diamatrix
DCP-VAR
In Commercial Distribution

  • 00813059017727 ()
DCP-VAR

  • Lacrimal punctum plug
DACRIOS 0.2mm X 2mm Collagen (Temporary) Punctal Plug, Box of 10
Diamatrix
DCP02
In Commercial Distribution

  • 00813059017710 ()
DCP02

  • Lacrimal punctum plug
DACRIOS 0.3mm X 2mm Collagen (Temporary) Punctal Plug, Box of 10
Diamatrix
DCP03
In Commercial Distribution

  • 00813059017703 ()
DCP03

  • Lacrimal punctum plug
DACRIOS 0.4mm X 2mm Collagen (Temporary) Punctal Plug, Box of 10
Diamatrix
DCP04
In Commercial Distribution

  • 00813059017697 ()
DCP04

  • Lacrimal punctum plug
DACRIOS .4mm Silicone Punctal Plug, Box of 2
Diamatrix
DDPS04
In Commercial Distribution

  • 00813059017680 ()
DDPS04

  • Lacrimal punctum plug
DACRIOS .5mm Silicone Punctal Plug, Box of 2
Diamatrix
DDPS05
In Commercial Distribution

  • 00813059017673 ()
DDPS05

  • Lacrimal punctum plug
DACRIOS .6mm Silicone Punctal Plug, Box of 2
Diamatrix
DDPS06
In Commercial Distribution

  • 00813059017666 ()
DDPS06

  • Lacrimal punctum plug
DACRIOS .7mm Silicone Punctal Plug, Box of 2
Diamatrix
DDPS07
In Commercial Distribution

  • 00813059017659 ()
DDPS07

  • Lacrimal punctum plug
DACRIOS .8mm Silicone Punctal Plug, Box of 2
Diamatrix
DPPS08
In Commercial Distribution

  • 00813059017642 ()
DPPS08

  • Lacrimal punctum plug
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