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 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
No Description
I.C. MEDICAL, INC.
ICM-000-0447
In Commercial Distribution

  • 00817688021797 ()


  • Surgical plume evacuation system
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Frame adapter thumb screw
In Commercial Distribution

  • 07290114061407 ()
700-001330-00

  • Depth electrode
No Description
ALPHA OMEGA ENGINEERING CO. LTD.
Frame adapter thumb screw - Pack of 3
In Commercial Distribution

  • 37290114061408 ()
700-001330-03

  • Depth electrode
A549 CELLS MWP W96/32 CUST
DIAGNOSTIC HYBRIDS, INC.
56-9632C
In Commercial Distribution

  • 30014613333234 ()
56-9632C

  • Cell culture line IVD
A549 CELLS MWP W96/24 CUST
DIAGNOSTIC HYBRIDS, INC.
56-9624C
In Commercial Distribution

  • 30014613333227 ()
56-9624C

  • Cell culture line IVD
A549 PLATE W48/48F
DIAGNOSTIC HYBRIDS, INC.
56-4848
In Commercial Distribution

  • 30014613333210 ()
56-4848

  • Cell culture line IVD
A549 W48/24
DIAGNOSTIC HYBRIDS, INC.
56-4824
In Commercial Distribution

  • 30014613333203 ()
56-4824

  • Cell culture line IVD
A549 W48/12
DIAGNOSTIC HYBRIDS, INC.
56-4812
In Commercial Distribution

  • 30014613333197 ()
56-4812

  • Cell culture line IVD
A549 W24/24
DIAGNOSTIC HYBRIDS, INC.
56-2424
In Commercial Distribution

  • 30014613333180 ()
56-2424

  • Cell culture line IVD
A549 W24/18
DIAGNOSTIC HYBRIDS, INC.
56-2418
In Commercial Distribution

  • 30014613333173 ()
56-2418

  • Cell culture line IVD
A549 W24/12
DIAGNOSTIC HYBRIDS, INC.
56-2412
In Commercial Distribution

  • 30014613333166 ()
56-2412

  • Cell culture line IVD
A549 W24/06
DIAGNOSTIC HYBRIDS, INC.
56-2406
In Commercial Distribution

  • 30014613333159 ()
56-2406

  • Cell culture line IVD
A549 6 WELL 6 FILL PLATE
DIAGNOSTIC HYBRIDS, INC.
56-0606
In Commercial Distribution

  • 30014613333142 ()
56-0606

  • Cell culture line IVD
A549 TUBE LIGHT DENSITY
DIAGNOSTIC HYBRIDS, INC.
56-0600L
In Commercial Distribution

  • 30014613333135 ()
56-0600L

  • Cell culture line IVD
A549 TUBE
DIAGNOSTIC HYBRIDS, INC.
56-0600
In Commercial Distribution

  • 30014613333128 ()
56-0600

  • Cell culture line IVD
A549 SV/CS
DIAGNOSTIC HYBRIDS, INC.
56-0102
In Commercial Distribution

  • 30014613333111 ()
56-0102

  • Cell culture line IVD
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