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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Gamma Camera System
Ddd-Diagnostic A/S
CardioMD Gamma Camera System
Not in Commercial Distribution

  • 05711665002029 ()

  • Width: 284 Centimeter
  • Depth: 150 Centimeter
  • Height: 150 Centimeter
  • Weight: 815 Kilogram
9PMS3060

  • Stationary gamma camera system
Gamma Camera System
Ddd-Diagnostic A/S
CorCam Gamma Camera System
In Commercial Distribution

  • 05711665002012 ()

  • Width: 284 Centimeter
  • Depth: 150 Centimeter
  • Height: 150 Centimeter
  • Weight: 815 Kilogram
9PMS3060

  • Stationary gamma camera system
Cambria NM Packing Block
SEASPINE ORTHOPEDICS CORPORATION
93-9834
In Commercial Distribution

  • 10889981093839 ()
93-9834

  • Bone graft packing block
Cambria NM Graft Packer
SEASPINE ORTHOPEDICS CORPORATION
93-9832
In Commercial Distribution

  • 10889981093815 ()
93-9832

  • Bone graft packing block
Cambria Graft Packing Block, Universal
SEASPINE ORTHOPEDICS CORPORATION
93-9005
In Commercial Distribution

  • 10889981092924 ()
93-9005

  • Bone graft packing block
Cambria Graft Packing Block
SEASPINE ORTHOPEDICS CORPORATION
93-9004
In Commercial Distribution

  • 10889981092917 ()
93-9004

  • Bone graft packing block
No Description
G E MEDICAL SYSTEMS ISRAEL LTD.
H3906DE
In Commercial Distribution

  • 00840682141635 ()


  • Full-body CT system
  • Stationary gamma camera system
CYNOSURE VIROVAC 220V SMOKE EVACUATOR/FILTER/NON-STERILE TUBING
Conmed Corporation
CYNOSUREVV220K
In Commercial Distribution

  • 30845854081116 ()
CYNOSUREVV220K

  • Surgical plume evacuation system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Long Bengun
In Commercial Distribution

  • 27290114064082 ()
700-020834-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
2
In Commercial Distribution

  • 27290114061104 ()
700-020834-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
CRW Non-XY frame Mechanical Set KIT
In Commercial Distribution

  • 27290016450952 ()
700-020834-00

  • Depth electrode
COUGAR SYSTEM FILLER BLOCK
DEPUY SPINE, LLC
273201400
In Commercial Distribution

  • 10705034187143 ()
273201400

  • Bone graft packing block
CONCORDE SYSTEM FILLER BLOCK
DEPUY SPINE, LLC
287906000
In Commercial Distribution

  • 10705034220123 ()
287906000

  • Bone graft packing block
ClearView Smoke Evacuation Unit with ClearView Smoke Evacuator Filter 100V-120V 50/60Hz
Conmed Corporation
60-8585-120
In Commercial Distribution

60-8585-120

  • Surgical plume evacuation system
ClearView Smoke Evacuation Unit with ClearView Smoke Evacuator Filter 220V-240V 50/60Hz
Conmed Corporation
60-8585-230
In Commercial Distribution

60-8585-230

  • Surgical plume evacuation system
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
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.
3326-0026
In Commercial Distribution

  • 08809885733919 ()
3326-0026

  • 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.
3326-0024
In Commercial Distribution

  • 08809885733902 ()
3326-0024

  • 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.
3326-0022
In Commercial Distribution

  • 08809885733896 ()
3326-0022

  • 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.
3326-0020
In Commercial Distribution

  • 08809885733889 ()
3326-0020

  • Spinal bone screw, non-bioabsorbable
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