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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The CASSIOPEIA Cervical Plate System is a multiple component system that comprises several sizes of plates and screws and associated manual surgical instruments. The CASSIOPEIA Cervical Plate System implants are supplied non-sterile, are single use, and are fabricated from medical grade titanium alloy (Ti6Al4V ELI, ASTM F 136) The CASSIOPEIA Cervical Plate System is intended for anterior cervical fixation (C2-C7) in skeletally mature patients as an adjunct to fusion for the following indications: Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Spondylolisthesis, Trauma (including fracture or dislocation), Spinal stenosis, Deformities or curvatures (kyphosis, lordosis, or scoliosis), Tumors, Pseudoarthrosis and Failed previous fusion.
GS Medical Co., Ltd.
3314-0016
In Commercial Distribution

  • 08809885733575 ()
3314-0016

  • Spinal bone screw, non-bioabsorbable
The CASSIOPEIA Cervical Plate System is a multiple component system that comprises several sizes of plates and screws and associated manual surgical instruments. The CASSIOPEIA Cervical Plate System implants are supplied non-sterile, are single use, and are fabricated from medical grade titanium alloy (Ti6Al4V ELI, ASTM F 136) The CASSIOPEIA Cervical Plate System is intended for anterior cervical fixation (C2-C7) in skeletally mature patients as an adjunct to fusion for the following indications: Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Spondylolisthesis, Trauma (including fracture or dislocation), Spinal stenosis, Deformities or curvatures (kyphosis, lordosis, or scoliosis), Tumors, Pseudoarthrosis and Failed previous fusion.
GS Medical Co., Ltd.
3314-0014
In Commercial Distribution

  • 08809885733568 ()
3314-0014

  • Spinal bone screw, non-bioabsorbable
The CASSIOPEIA Cervical Plate System is a multiple component system that comprises several sizes of plates and screws and associated manual surgical instruments. The CASSIOPEIA Cervical Plate System implants are supplied non-sterile, are single use, and are fabricated from medical grade titanium alloy (Ti6Al4V ELI, ASTM F 136) The CASSIOPEIA Cervical Plate System is intended for anterior cervical fixation (C2-C7) in skeletally mature patients as an adjunct to fusion for the following indications: Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Spondylolisthesis, Trauma (including fracture or dislocation), Spinal stenosis, Deformities or curvatures (kyphosis, lordosis, or scoliosis), Tumors, Pseudoarthrosis and Failed previous fusion.
GS Medical Co., Ltd.
3314-0012
In Commercial Distribution

  • 08809885733551 ()
3314-0012

  • Spinal bone screw, non-bioabsorbable
The CASSIOPEIA Cervical Plate System is a multiple component system that comprises several sizes of plates and screws and associated manual surgical instruments. The CASSIOPEIA Cervical Plate System implants are supplied non-sterile, are single use, and are fabricated from medical grade titanium alloy (Ti6Al4V ELI, ASTM F 136) The CASSIOPEIA Cervical Plate System is intended for anterior cervical fixation (C2-C7) in skeletally mature patients as an adjunct to fusion for the following indications: Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Spondylolisthesis, Trauma (including fracture or dislocation), Spinal stenosis, Deformities or curvatures (kyphosis, lordosis, or scoliosis), Tumors, Pseudoarthrosis and Failed previous fusion.
GS Medical Co., Ltd.
3324-0018
In Commercial Distribution

  • 08809885720025 ()
3324-0018

  • Spinal fixation plate, non-bioabsorbable
The CASSIOPEIA Cervical Plate System is a multiple component system that comprises several sizes of plates and screws and associated manual surgical instruments. The CASSIOPEIA Cervical Plate System implants are supplied non-sterile, are single use, and are fabricated from medical grade titanium alloy (Ti6Al4V ELI, ASTM F 136) The CASSIOPEIA Cervical Plate System is intended for anterior cervical fixation (C2-C7) in skeletally mature patients as an adjunct to fusion for the following indications: Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Spondylolisthesis, Trauma (including fracture or dislocation), Spinal stenosis, Deformities or curvatures (kyphosis, lordosis, or scoliosis), Tumors, Pseudoarthrosis and Failed previous fusion.
GS Medical Co., Ltd.
3324-0016
In Commercial Distribution

  • 08809885709778 ()
3324-0016

  • Spinal fixation plate, non-bioabsorbable
The CASSIOPEIA Cervical Plate System is a multiple component system that comprises several sizes of plates and screws and associated manual surgical instruments. The CASSIOPEIA Cervical Plate System implants are supplied non-sterile, are single use, and are fabricated from medical grade titanium alloy (Ti6Al4V ELI, ASTM F 136) The CASSIOPEIA Cervical Plate System is intended for anterior cervical fixation (C2-C7) in skeletally mature patients as an adjunct to fusion for the following indications: Degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), Spondylolisthesis, Trauma (including fracture or dislocation), Spinal stenosis, Deformities or curvatures (kyphosis, lordosis, or scoliosis), Tumors, Pseudoarthrosis and Failed previous fusion.
GS Medical Co., Ltd.
3324-0012
In Commercial Distribution

  • 08800104099960 ()
3324-0012

  • Spinal fixation plate, non-bioabsorbable
ePlex Respiratory Panel Kit, 12 test, IVD
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005030 ()
EA001012

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
ePlex Sample Delivery Device RP Panel
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005023 ()
KT022006

  • Multiple-genus respiratory virus antigen IVD, kit, multiplex
Respiratory Panel Cartridge
GENMARK DIAGNOSTICS, INC.
ePlex Respiratory Panel (RP)
In Commercial Distribution

  • 00857167005016 ()
KT022287

  • Hepatitis G virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Decellularized Bovine Pericardium
GENESEE BIOMEDICAL, INC.
PFP6x8
In Commercial Distribution

  • B040PFP6X81 ()
N/A

  • Cardiovascular patch, animal-derived
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