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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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DEPTHALON® - 00650551068952

DEPTH ELECTRODE, PLATINUM, 6 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2102-06-085-NS
In Commercial Distribution

  • 00650551068952 ()

  • Spacing 10 Millimeter
  • Recording Depth 52 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 32 Centimeter
2102-06-085-NS

  • Depth electrode

DEPTHALON® - 00650551068945

DEPTH ELECTRODE, PLATINUM, 6 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2102-06-072-NS
In Commercial Distribution

  • 00650551068945 ()

  • Spacing 10 Millimeter
  • Recording Depth 55 Millimeter
  • Contact Length 5 Millimeter
  • Main Tube Length 32 Centimeter
2102-06-072-NS

  • Depth electrode

DEPTHALON® - 00650551068938

DEPTH ELECTRODE, PLATINUM, 6 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2102-06-071-NS
In Commercial Distribution

  • 00650551068938 ()

  • Spacing 11 Millimeter
  • Recording Depth 60 Millimeter
  • Contact Length 5 Millimeter
  • Main Tube Length 32 Centimeter
2102-06-071-NS

  • Depth electrode

DEPTHALON® - 00650551068921

DEPTH ELECTRODE, PLATINUM, 6 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2102-06-051-NS
In Commercial Distribution

  • 00650551068921 ()

  • Spacing 7 Millimeter
  • Recording Depth 37 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 32 Centimeter
2102-06-051-NS

  • Depth electrode

DEPTHALON® - 00650551068914

DEPTH ELECTRODE, PLATINUM, 6 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2102-06-041-NS
In Commercial Distribution

  • 00650551068914 ()

  • Main Tube Length 32 Centimeter
  • Contact Length 5 Millimeter
  • Recording Depth 55 Millimeter
  • Spacing 10 Millimeter
2102-06-041-NS

  • Depth electrode

DEPTHALON® - 00650551068907

DEPTH ELECTRODE, PLATINUM, 6 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2102-06-039-NS
In Commercial Distribution

  • 00650551068907 ()

  • Spacing 7.5 Millimeter
  • Recording Depth 42.5 Millimeter
  • Contact Length 5 Millimeter
  • Main Tube Length 32 Centimeter
2102-06-039-NS

  • Depth electrode

DEPTHALON® - 00650551068891

DEPTH ELECTRODE, PLATINUM, 6 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2102-06-038-NS
In Commercial Distribution

  • 00650551068891 ()

  • Spacing 5.6 Millimeter
  • Recording Depth 30 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 32 Centimeter
2102-06-038-NS

  • Depth electrode

DEPTHALON® - 00650551068884

DEPTH ELECTRODE, PLATINUM, 6 CONTACT, MINI CONNECTOR
PMT CORPORATION
2102-06-037-NS
In Commercial Distribution

  • 00650551068884 ()

  • Spacing 5 Millimeter
  • Recording Depth 27 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 32 Centimeter
2102-06-037-NS

  • Depth electrode

DEPTHALON® - 00650551068846

DEPTH ELECTRODE, PLATINUM, 6 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2102-06-003-NS
In Commercial Distribution

  • 00650551068846 ()

  • Main Tube Length 32 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 42 Millimeter
  • Spacing 8 Millimeter
2102-06-003-NS

  • Depth electrode

DEPTHALON® - 00650551068822

DEPTH ELECTRODE, PLATINUM, 6 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2102-06-001-NS
In Commercial Distribution

  • 00650551068822 ()

  • Main Tube Length 36 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 27 Millimeter
  • Spacing 5 Millimeter
2102-06-001-NS

  • Depth electrode

DEPTHALON® - 00650551068808

DEPTH ELECTRODE, PLATINUM, 4 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2102-04-IL-SS-NS
In Commercial Distribution

  • 00650551068808 ()

  • Spacing 10 Millimeter
  • Recording Depth 44 Millimeter
  • Contact Length 5 Millimeter
  • Main Tube Length 32 Centimeter
2102-04-IL-SS-NS

  • Depth electrode

DEPTHALON® - 00650551068785

DEPTH ELECTRODE, PLATINUM, 4 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2102-04-201-NS
In Commercial Distribution

  • 00650551068785 ()

  • Spacing 5 Millimeter
  • Recording Depth 17 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 35.5 Centimeter
2102-04-201-NS

  • Depth electrode

DEPTHALON® - 00650551068693

DEPTH ELECTRODE, PLATINUM, 4 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2102-04-053-NS
In Commercial Distribution

  • 00650551068693 ()

  • Spacing 5 Millimeter
  • Recording Depth 17 Millimeter
  • Contact Length 2 Millimeter
  • Main Tube Length 35 Centimeter
2102-04-053-NS

  • Depth electrode

DEPTHALON® - 00650551068679

DEPTH ELECTRODE, PLATINUM, 4 CONTACT, INLINE CONNECTOR
PMT CORPORATION
2102-04-036-NS
In Commercial Distribution

  • 00650551068679 ()

  • Main Tube Length 36 Centimeter
  • Contact Length 2 Millimeter
  • Recording Depth 17 Millimeter
  • Spacing 5 Millimeter
2102-04-036-NS

  • Depth electrode

ACCUNAV® - 00650551068440

DEPTH ELECTRODE, PLATINUM, 8 CONTACT (2MM), INLINE CONNECTOR
PMT CORPORATION
2102-08-120-NS
In Commercial Distribution

  • 00650551068440 ()

  • Spacing 5 Millimeter
  • Recording Depth 37 Millimeter
  • Outer Diameter: 1.8 Millimeter
2102-08-120-NS

  • Depth electrode

ACCUNAV® - 00650551068433

DEPTH ELECTRODE, PLATINUM, 6 CONTACT (2MM), INLINE CONNECTOR
PMT CORPORATION
2102-06-121-NS
In Commercial Distribution

  • 00650551068433 ()

  • Outer Diameter: 1.8 Millimeter
  • Recording Depth 52 Millimeter
  • Spacing 10 Millimeter
2102-06-121-NS

  • Depth electrode

ACCUNAV® - 00650551068419

DEPTH ELECTRODE, PLATINUM, 4 CONTACT (2MM), INLINE CONNECTOR
PMT CORPORATION
2102-04-121-NS
In Commercial Distribution

  • 00650551068419 ()

  • Outer Diameter: 1.8 Millimeter
  • Recording Depth 32 Millimeter
  • Spacing 10 Millimeter
2102-04-121-NS

  • Depth electrode

Gmate® Origin Blood Glucose Monitoring System - 08809301160206

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

  • 08809301160206 ()


  • Glucose monitoring system IVD, home-use

Gmate® Origin Blood Glucose Monitoring System - 08809301160145

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

  • 08809301160145 ()


  • Glucose monitoring system IVD, home-use

Gmate® Origin Blood Glucose Monitoring System - 08809301160077

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

  • 08809301160077 ()


  • Glucose monitoring system IVD, home-use

Orthopaedic & Spine Development (OSD) - 03760178394857

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

  • 03760178394857 ()


  • General internal orthopaedic fixation system implantation kit

Orthopaedic & Spine Development (OSD) - 03760178394833

Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-TPC-0001
In Commercial Distribution

  • 03760178394833 ()


  • General internal orthopaedic fixation system implantation kit

Orthopaedic & Spine Development (OSD) - 03760178394826

Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-SQA-0025
In Commercial Distribution

  • 03760178394826 ()


  • General internal orthopaedic fixation system implantation kit

Orthopaedic & Spine Development (OSD) - 03760178394802

Instrument to use with ORIGIN implants
ORTHOPAEDIC & SPINE DEVELOPMENT
A-CPL-0002
In Commercial Distribution

  • 03760178394802 ()


  • General internal orthopaedic fixation system implantation kit

Orthopaedic & Spine Development (OSD) - 03760178394840

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

  • 03760178394840 ()


  • General internal orthopaedic fixation system implantation kit

Omnia Medical VBR - 00843511100421

Omnia Medical VBR, Graft Packing Block
OMNIA MEDICAL, LLC
06-5V-PAC1
In Commercial Distribution

  • 00843511100421 ()
06-5V-PAC1

  • Bone graft packing block

Neurolutions Ipsihand Upper Extremity Rehabilitation System - 00850005539025

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

Neurolutions Ipsihand Upper Extremity Rehabilitation System - 00850005539018

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

FOCUS - 00814008027422

Rod, Straight 5.5X35mm. 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.
S-01-035
In Commercial Distribution

  • 00814008027422 ()

  • Length: 35 Millimeter
  • Outer Diameter: 5.5 Millimeter


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

FOCUS - 00814008027415

Rod, Straight 5.5X30mm. 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.
S-01-030
In Commercial Distribution

  • 00814008027415 ()

  • Outer Diameter: 5.5 Millimeter
  • Length: 30 Millimeter


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