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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Pedicle Screw Case 2 Base, Implants. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000C-211
In Commercial Distribution

  • 00810005662147 ()


  • Surgical instrument/implant rack
Pedicle Screw Case 1 INSERT 2. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000C-202
In Commercial Distribution

  • 00810005662130 ()


  • Surgical instrument/implant rack
Pedicle Screw Case 1 INSERT 1. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000C-203
In Commercial Distribution

  • 00810005662123 ()


  • Surgical instrument/implant rack
Pedicle Screw Case 1 Lid. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000C-101
In Commercial Distribution

  • 00810005662116 ()


  • Surgical instrument/implant rack
Pedicle Screw Case 1 Base, Implants. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
PD-1000C-201
In Commercial Distribution

  • 00810005662109 ()


  • Surgical instrument/implant rack
MCCOY FLK 150 SQ CM
DIAGNOSTIC HYBRIDS, INC.
54-T150
In Commercial Distribution

  • 30014613332947 ()
54-T150

  • Cell culture line IVD
MCCOY FLK 75 SQ CM
DIAGNOSTIC HYBRIDS, INC.
54-T075
In Commercial Distribution

  • 30014613332930 ()
54-T075

  • Cell culture line IVD
MCCOY W96/96
DIAGNOSTIC HYBRIDS, INC.
54-9696
In Commercial Distribution

  • 30014613332923 ()
54-9696

  • Cell culture line IVD
MCCOY W48/48
DIAGNOSTIC HYBRIDS, INC.
54-4848
In Commercial Distribution

  • 30014613332916 ()
54-4848

  • Cell culture line IVD
MCCOY W48/36
DIAGNOSTIC HYBRIDS, INC.
54-4836C
In Commercial Distribution

  • 30014613332909 ()
54-4836C

  • Cell culture line IVD
MCCOY W48/24
DIAGNOSTIC HYBRIDS, INC.
54-4824
In Commercial Distribution

  • 30014613332893 ()
54-4824

  • Cell culture line IVD
MCCOY W48/18
DIAGNOSTIC HYBRIDS, INC.
54-4818
In Commercial Distribution

  • 30014613332886 ()
54-4818

  • Cell culture line IVD
MCCOY W48/12
DIAGNOSTIC HYBRIDS, INC.
54-4812
In Commercial Distribution

  • 30014613332879 ()
54-4812

  • Cell culture line IVD
MCCOY W48/06
DIAGNOSTIC HYBRIDS, INC.
54-4806
In Commercial Distribution

  • 30014613332862 ()
54-4806

  • Cell culture line IVD
MCCOY W24/24 WITH CS
DIAGNOSTIC HYBRIDS, INC.
54-2424S
In Commercial Distribution

  • 30014613332855 ()
54-2424S

  • Cell culture line IVD
MCCOY W24/24
DIAGNOSTIC HYBRIDS, INC.
54-2424
In Commercial Distribution

  • 30014613332848 ()
54-2424

  • Cell culture line IVD
MCCOY W24/18
DIAGNOSTIC HYBRIDS, INC.
54-2418
In Commercial Distribution

  • 30014613332831 ()
54-2418

  • Cell culture line IVD
MCCOY W24/12 WITH CS
DIAGNOSTIC HYBRIDS, INC.
54-2412S
In Commercial Distribution

  • 30014613332824 ()
54-2412S

  • Cell culture line IVD
MCCOY W24/12
DIAGNOSTIC HYBRIDS, INC.
54-2412
In Commercial Distribution

  • 30014613332817 ()
54-2412

  • Cell culture line IVD
MCCOY PLATES
DIAGNOSTIC HYBRIDS, INC.
54-2406
In Commercial Distribution

  • 30014613332800 ()
54-2406

  • Cell culture line IVD
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