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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MICROWIRE DEPTHALON ELECTRODE, 16 MICROWIRE CONTACTS, MINI CONNECTOR
PMT CORPORATION
2104-08-16-001-NS
In Commercial Distribution

  • 00650551095996 ()

  • Contact Size 1.4 Millimeter
  • Microwire Diameter 40 Micrometer
2104-08-16-001-NS

  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 8 MICROWIRE CONTACTS, INLINE CONNECTOR
PMT CORPORATION
2104-08-08-003-NS
In Commercial Distribution

  • 00650551095989 ()

  • Main Tube Length 32 Centimeter
  • Microwire Diameter 40 Micrometer
  • Contact Size 2 Millimeter
2104-08-08-003-NS

  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 8 MICROWIRE CONTACTS, INLINE CONNECTOR
PMT CORPORATION
2104-08-08-002-NS
In Commercial Distribution

  • 00650551095972 ()

  • Contact Size 2 Millimeter
  • Microwire Diameter 40 Micrometer
  • Main Tube Length 32 Centimeter
2104-08-08-002-NS

  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 16 MICROWIRE CONTACTS, 2 SHIELDED INLINE TAILS WITH 10CM LEAD
PMT CORPORATION
2104-04-16-03-104-NS
In Commercial Distribution

  • 00650551095965 ()

  • Main Tube Length 30 Centimeter
  • Microwire Diameter 40 Micrometer
  • Contact Size 2 Millimeter
2104-04-16-03-104-NS

  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 16 MICROWIRE CONTACTS, 2 SHIELDED INLINE TAILS WITH 10CM LEAD
PMT CORPORATION
2104-04-16-03-103-NS
In Commercial Distribution

  • 00650551095958 ()

  • Contact Size 2 Millimeter
  • Microwire Diameter 40 Micrometer
  • Main Tube Length 30 Centimeter
2104-04-16-03-103-NS

  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 16 MICROWIRE CONTACTS, 2 SHIELDED INLINE TAILS
PMT CORPORATION
2104-04-16-03-102-NS
In Commercial Distribution

  • 00650551095941 ()

  • Main Tube Length 30 Centimeter
  • Microwire Diameter 40 Micrometer
  • Contact Size 2 Millimeter
2104-04-16-03-102-NS

  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 32 MICROWIRE CONTACTS, 3 SHIELDED INLINE TAILS
PMT CORPORATION
2104-04-16-02-053-NS
In Commercial Distribution

  • 00650551095934 ()

  • Microwire Diameter 40 Micrometer
  • Main Tube Length 30 Centimeter
  • Contact Size 2 Millimeter
2104-04-16-02-053-NS

  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 32 MICROWIRE CONTACTS, 3 SHIELDED INLINE TAILS
PMT CORPORATION
2104-04-16-02-052-NS
In Commercial Distribution

  • 00650551095927 ()

  • Contact Size 2 Millimeter
  • Microwire Diameter 40 Micrometer
  • Main Tube Length 30 Centimeter
2104-04-16-02-052-NS

  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 8 MICROWIRE CONTACTS, MINI CONNECTOR
PMT CORPORATION
2104-00-08-009-NS
In Commercial Distribution

  • 00650551095910 ()

  • Main Tube Length 15 Centimeter
  • Microwire Diameter 25 Micrometer
2104-00-08-009-NS

  • Depth electrode
PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED, 2 LOOSE CONNECTORS
PMT CORPORATION
2102-32-09-NS
In Commercial Distribution

  • 10650551092992 ()
  • 00650551092995 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 22 Gauge
  • Recording Length 0.25 Inch
2102-32-09-NS

  • Depth electrode
PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED, BLUE DEPTH STOP ON NEEDLE
PMT CORPORATION
2102-32-05-NS
In Commercial Distribution

  • 10650551092961 ()
  • 00650551092964 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 22 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2102-32-05-NS

  • Depth electrode
PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED
PMT CORPORATION
2102-32-03-NS
In Commercial Distribution

  • 10650551092954 ()
  • 00650551092957 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 21 Gauge
  • Recording Length 0.25 Inch
2102-32-03-NS

  • Depth electrode
PLATINUM ELECTRODE, WITH NEEDLE, WITHOUT CABLE, CRIMPED
PMT CORPORATION
2102-31-03-NS
In Commercial Distribution

  • 10650551092930 ()
  • 00650551092933 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 21 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2102-31-03-NS

  • Depth electrode
STAINLESS STEEL ELECTRODE, WITH NEEDLE, WITHOUT CABLE, NON-CRIMPED
PMT CORPORATION
2101-32-03-NS
In Commercial Distribution

  • 10650551092916 ()
  • 00650551092919 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 21 Gauge
  • Recording Length 0.25 Inch
2101-32-03-NS

  • Depth electrode
STAINLESS STEEL ELECTRODE, WITH NEEDLE, WITHOUT CABLE, CRIMPED
PMT CORPORATION
2101-31-03-NS
In Commercial Distribution

  • 10650551092893 ()
  • 00650551092896 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 21 Gauge
  • Recording Length 0.25 Inch
2101-31-03-NS

  • Depth electrode
SPHENOIDAL ELECTRODE EEG CABLE 1.5MM SOCKET SET
PMT CORPORATION
2122NS
In Commercial Distribution

  • 10650551092879 ()
  • 00650551092872 ()
2122NS

  • Depth electrode
Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-TPC-0002-02
In Commercial Distribution

  • 03760178394857 ()


  • General internal orthopaedic fixation system implantation kit
Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-TPC-0002
In Commercial Distribution

  • 03760178394840 ()


  • General internal orthopaedic fixation system implantation kit
Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-TPC-0001
In Commercial Distribution

  • 03760178394833 ()


  • General internal orthopaedic fixation system implantation kit
Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-SQA-0025
In Commercial Distribution

  • 03760178394826 ()


  • General internal orthopaedic fixation system implantation kit
Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-CPL-0002
In Commercial Distribution

  • 03760178394802 ()


  • General internal orthopaedic fixation system implantation kit
PsiF Post Packer (Long Impactor) Instrument
OMNIA MEDICAL, LLC
01-01-0010
In Commercial Distribution

  • 00843511100636 ()
01-01-0010

  • Bone graft packing block
Omnia Medical VBR, Graft Packing Block
OMNIA MEDICAL, LLC
06-5V-PAC1
In Commercial Distribution

  • 00843511100421 ()
06-5V-PAC1

  • Bone graft packing block
Tower Dis-Engage Instrument. 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-1000T-110
In Commercial Distribution

  • 00814008029822 ()


  • General internal orthopaedic fixation system implantation kit
Small Ratcheting T-Handle. 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-1000T-109
In Commercial Distribution

  • 00814008029815 ()


  • General internal orthopaedic fixation system implantation kit
Awl Small. 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-1000T-112
In Commercial Distribution

  • 00814008029778 ()


  • General internal orthopaedic fixation system implantation kit
Cross Connector Screw Driver. 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-1000T-108
In Commercial Distribution

  • 00814008029754 ()


  • General internal orthopaedic fixation system implantation kit
Rod Template. 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-1000T-107
In Commercial Distribution

  • 00814008029747 ()


  • General internal orthopaedic fixation system implantation kit
Rod, MIS, Lordotic 5.5X130mm. 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.
M-01-130
In Commercial Distribution

  • 00814008029730 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 130 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, MIS, Lordotic 5.5X120mm. 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.
M-01-120
In Commercial Distribution

  • 00814008029723 ()

  • Length: 120 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, MIS, Lordotic 5.5X110mm. 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.
M-01-110
In Commercial Distribution

  • 00814008029716 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 110 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, MIS, Lordotic 5.5X100mm. 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.
M-01-100
In Commercial Distribution

  • 00814008029709 ()

  • Length: 100 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, MIS, Lordotic 5.5X90mm. 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.
M-01-090
In Commercial Distribution

  • 00814008029693 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 90 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, MIS, Lordotic 5.5X80mm. 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.
M-01-080
In Commercial Distribution

  • 00814008029686 ()

  • Length: 80 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, MIS, Lordotic 5.5X70mm. 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.
M-01-070
In Commercial Distribution

  • 00814008029679 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 70 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, MIS, Lordotic 5.5X65mm. 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.
M-01-065
In Commercial Distribution

  • 00814008029662 ()

  • Length: 65 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, MIS, Lordotic 5.5X60mm. 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.
M-01-060
In Commercial Distribution

  • 00814008029655 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 60 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, MIS, Lordotic 5.5X55mm. 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.
M-01-055
In Commercial Distribution

  • 00814008029648 ()

  • Length: 55 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, MIS, Lordotic 5.5X50mm. 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.
M-01-050
In Commercial Distribution

  • 00814008029631 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 50 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
Rod, MIS, Lordotic 5.5X45mm. 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.
M-01-045
In Commercial Distribution

  • 00814008029624 ()

  • Length: 45 Millimeter
  • Outer Diameter: 5.5 Millimeter


  • Bone-screw internal spinal fixation system, non-sterile
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