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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sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-096-NS
In Commercial Distribution

  • 00650551070276 ()

  • Outer Diameter: 0.8 Millimeter
  • Spacing 4.43 Millimeter
  • Recording Depth 68.5 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 27 Centimeter
2102-16-096-NS

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-105-NS
In Commercial Distribution

  • 00650551070269 ()

  • Main Tube Length 27 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 61.5 Millimeter
  • Spacing 3.97 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-105-NS

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-095-NS
In Commercial Distribution

  • 00650551070252 ()

  • Outer Diameter: 0.8 Millimeter
  • Spacing 3.97 Millimeter
  • Recording Depth 61.5 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 27 Centimeter
2102-16-095-NS

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-16-104-NS
In Commercial Distribution

  • 00650551070245 ()

  • Main Tube Length 27 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 54.5 Millimeter
  • Spacing 3.5 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-16-104-NS

  • Depth electrode
sEEG, PLATINUM, 16 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-16-094-NS
In Commercial Distribution

  • 00650551070238 ()

  • Outer Diameter: 0.8 Millimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 54.5 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 27 Centimeter
2102-16-094-NS

  • Depth electrode
sEEG, PLATINUM, 14 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-14-104-NS
In Commercial Distribution

  • 00650551070221 ()

  • Main Tube Length 27 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 47.5 Millimeter
  • Spacing 3.5 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-14-104-NS

  • Depth electrode
sEEG, PLATINUM, 14 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-14-094-NS
In Commercial Distribution

  • 00650551070214 ()

  • Outer Diameter: 0.8 Millimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 47.5 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 27 Centimeter
2102-14-094-NS

  • Depth electrode
sEEG, PLATINUM, 12 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-12-104-NS
In Commercial Distribution

  • 00650551070207 ()

  • Main Tube Length 27 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 40.5 Millimeter
  • Spacing 3.5 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-12-104-NS

  • Depth electrode
sEEG, PLATINUM, 12 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-12-094-NS
In Commercial Distribution

  • 00650551070191 ()

  • Outer Diameter: 0.8 Millimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 40.5 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 27 Centimeter
2102-12-094-NS

  • Depth electrode
sEEG, PLATINUM, 10 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-10-104-NS
In Commercial Distribution

  • 00650551070184 ()

  • Main Tube Length 27 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 33.5 Millimeter
  • Spacing 3.5 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-10-104-NS

  • Depth electrode
sEEG, PLATINUM, 10 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-10-094-NS
In Commercial Distribution

  • 00650551070177 ()

  • Outer Diameter: 0.8 Millimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 33.5 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 27 Centimeter
2102-10-094-NS

  • Depth electrode
sEEG, PLATINUM, 8 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.1MM DRILL
PMT CORPORATION
2102-08-104-NS
In Commercial Distribution

  • 00650551070160 ()

  • Main Tube Length 27 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 26.5 Millimeter
  • Spacing 3.5 Millimeter
  • Outer Diameter: 0.8 Millimeter
2102-08-104-NS

  • Depth electrode
sEEG, PLATINUM, 8 CONTACT, MINI CONNECTOR, PERMANENT STYLET, FOR 2.4MM DRILL
PMT CORPORATION
2102-08-094-NS
In Commercial Distribution

  • 00650551070153 ()

  • Outer Diameter: 0.8 Millimeter
  • Spacing 3.5 Millimeter
  • Recording Depth 26.5 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 27 Centimeter
2102-08-094-NS

  • Depth electrode
sEEG DEPTH ELECTRODE, 4 MACRO CONTACTS, 12.5 MICRO CONTACTS, MINI CONNECTOR, 1 EXIT, 1 LEAD, 1 TAIL, NON-STERILE
PMT CORPORATION
2102-04-091-NS
In Commercial Distribution

  • 00650551025412 ()


  • Depth electrode
SEEG, PLATINUM, 2MM X 4 CONTACTS, 0.5MM X 12 CONTACTS, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL, 0.8MM OD, 25MM RECORDING DEPTH, NON-STANDARD SPACING, 27CM MAIN TUBE LENGTH, NON-STERILE
PMT CORPORATION
2102-16-185-NS
In Commercial Distribution

  • 00650551002659 ()


  • Depth electrode
SEEG, PLATINUM, 2MM X 4 CONTACTS, 0.5MM X 12 CONTACTS, MINI CONNECTOR, REMOVABLE STYLET, FOR 2.1MM DRILL, 0.8MM OD, 25MM RECORDING DEPTH, NON-STANDARD SPACING, 27CM MAIN TUBE LENGTH, NON-STERILE
PMT CORPORATION
2102-16-184-NS
In Commercial Distribution

  • 00650551002642 ()


  • Depth electrode
SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 41MM RECORDING DEPTH, REMOVABLE STYLET, 2.4MM DRILL. NON-STERILE
PMT CORPORATION
2102-16-177-NS
In Commercial Distribution

  • 00650551001140 ()


  • Depth electrode
SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 48MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL, NON-STERILE
PMT CORPORATION
2102-16-176-NS
In Commercial Distribution

  • 00650551000860 ()


  • Depth electrode
SEEG, 16 CONTACT, 4 X 2MM & 12 X 0.5MM CONTACT SIZE, 44.5MM RECORDING DEPTH, MINI CONNECTOR, REMOVABLE STYLET, 2.4MM DRILL, NON-STERILE
PMT CORPORATION
2102-16-175-NS
In Commercial Distribution

  • 00650551000853 ()


  • Depth electrode
MICROWIRE DEPTHALON ELECTRODE, 1.5MM CONTACTS MARCO CONTACT DIA., 8 MACRO CONTACTS, 16 MICROWIRE CONTACTS, 51.1MM RECORDING LENGTH, MINI CONNECTOR, NON-STERILE
PMT CORPORATION
2104-08-16-006-NS
In Commercial Distribution

  • 00650551000471 ()


  • Depth electrode
PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED
PMT CORPORATION
2102-32-07-NS
In Commercial Distribution

  • 00650551092988 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 22 Gauge
  • Recording Length 0.03125 Inch
2102-32-07-NS

  • Depth electrode
PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED, BLUE DEPTH STOP ON NEEDLE
PMT CORPORATION
2102-32-06-NS
In Commercial Distribution

  • 00650551092971 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 22 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2102-32-06-NS

  • Depth electrode
PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED
PMT CORPORATION
2102-32-01-NS
In Commercial Distribution

  • 10650551092947 ()
  • 00650551092940 ()

  • Wire Gauge 36 Gauge
  • Length: 30 Centimeter
  • Tip Size 3-5 Millimeter
  • Needle Gauge: 21 Gauge
  • Recording Length 0.25 Inch
2102-32-01-NS

  • Depth electrode
PLATINUM ELECTRODE, WITH NEEDLE AND CABLE, CRIMPED
PMT CORPORATION
2102-31-01-NS
In Commercial Distribution

  • 10650551092923 ()
  • 00650551092926 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 21 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2102-31-01-NS

  • Depth electrode
STAINLESS STEEL ELECTRODE, WITH NEEDLE AND CABLE, NON-CRIMPED
PMT CORPORATION
2101-32-01-NS
In Commercial Distribution

  • 10650551092909 ()
  • 00650551092902 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 21 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2101-32-01-NS

  • Depth electrode
STAINLESS STEEL ELECTRODE, WITH NEEDLE AND CABLE, CRIMPED
PMT CORPORATION
2101-31-01-NS
In Commercial Distribution

  • 10650551092886 ()
  • 00650551092889 ()

  • Recording Length 0.25 Inch
  • Needle Gauge: 21 Gauge
  • Tip Size 3-5 Millimeter
  • Length: 30 Centimeter
  • Wire Gauge 36 Gauge
2101-31-01-NS

  • Depth electrode
CRIMPING TOOL FOR NON-CRIMPED SPHENOIDAL ELECTRODE
PMT CORPORATION
2105
In Commercial Distribution

  • 00650551092797 ()
2105

  • Depth electrode
No Description
PHILOSYS Co., Ltd
PG-310
In Commercial Distribution

  • 08809301160206 ()


  • Glucose monitoring system IVD, home-use
No Description
PHILOSYS Co., Ltd
PG-310
In Commercial Distribution

  • 08809301160145 ()


  • Glucose monitoring system IVD, home-use
No Description
PHILOSYS Co., Ltd
PG-310
In Commercial Distribution

  • 08809301160077 ()


  • Glucose monitoring system IVD, home-use
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
Omnia Medical VBR, Graft Packing Block
OMNIA MEDICAL, LLC
06-5V-PAC1
In Commercial Distribution

  • 00843511100421 ()
06-5V-PAC1

  • Bone graft packing block
The Neurolutions System is a Brain-Computer-Interface (BCI) device developed for rehabilitation of upper extremity disability for chronic stroke patients. The device consists of the Neurolutions robotic handpiece, a biometric headset, and a Windows-based tablet computer. The Neurolutions System provides upper extremity rehabilitation using three separate modes: the main mode of therapy is referred to as the BCI or ‘thought’ mode, in which the patient’s hand is opened or closed by the Orthosis based on brain-signals received from the biometric headset; the second mode is referred to as a ‘volitional’ mode in which a patient actively opens and closes their hand with the System enabling independent range of motion; the third is a continuous passive motion (CPM) mode in which the System simply moves the patient’s hand passively through a comfortable range of motion in a repetitive fashion.
Neurolutions, Inc
FGS-1000-02
In Commercial Distribution

  • 00850005539025 ()


  • Neuro-controlled joint movement exoskeleton
The Neurolutions System is a Brain-Computer-Interface (BCI) device developed for rehabilitation of upper extremity disability for chronic stroke patients. The device consists of the Neurolutions robotic handpiece, a biometric headset, and a Windows-based tablet computer. The Neurolutions System provides upper extremity rehabilitation using three separate modes: the main mode of therapy is referred to as the BCI or ‘thought’ mode, in which the patient’s hand is opened or closed by the Orthosis based on brain-signals received from the biometric headset; the second mode is referred to as a ‘volitional’ mode in which a patient actively opens and closes their hand with the System enabling independent range of motion; the third is a continuous passive motion (CPM) mode in which the System simply moves the patient’s hand passively through a comfortable range of motion in a repetitive fashion.
Neurolutions, Inc
FGS-1000-01
In Commercial Distribution

  • 00850005539018 ()


  • Neuro-controlled joint movement exoskeleton
Anterior Cervical Plating System, 4.25mm dia. 20mm long variable screw. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-425-20V
In Commercial Distribution

  • 90814008023847 ()

  • Height: 20 Millimeter
  • Width: 4.25 Millimeter
  • Depth: 4.25 Millimeter


  • Intervertebral-body internal spinal fixation system
Anterior Cervical Plating System, 4.75mm dia. 14mm long variable screw. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosis
NVISION BIOMEDICAL TECHNOLOGIES, INC.
ACP-475-14V
In Commercial Distribution

  • 90814008023809 ()

  • Height: 14 Millimeter
  • Width: 4.75 Millimeter
  • Depth: 4.75 Millimeter
ACP-475-14V

  • Intervertebral-body internal spinal fixation system
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