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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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Dymaxeon® - 00815500020157

DYMAXEON OPEN MONOAXIAL PEDICULAR SCREW Ø5.5 x50mm (BLUE)
BACK 2 BASIC DIRECT, LLC
06.0
In Commercial Distribution

  • 00815500020157 ()
  • 10815500020154 ()

  • Length: 50 Millimeter
06.2350B

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon® - 00815500020140

DYMAXEON OPEN MONOAXIAL PEDICULAR SCREW Ø5.5 x45mm (BLUE)
BACK 2 BASIC DIRECT, LLC
06.0
In Commercial Distribution

  • 00815500020140 ()
  • 10815500020147 ()

  • Length: 45 Millimeter
06.2345B

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon® - 00815500020133

DYMAXEON OPEN MONOAXIAL PEDICULAR SCREW Ø5.5 x40mm (BLUE)
BACK 2 BASIC DIRECT, LLC
06.0
In Commercial Distribution

  • 00815500020133 ()
  • 10815500020130 ()

  • Length: 40 Millimeter
06.2340B

  • Bone-screw internal spinal fixation system, sterile

Dymaxeon® - 00815500020119

DYMAXEON OPEN MONOAXIAL PEDICULAR SCREW Ø5 x70mm (YELLOW)
BACK 2 BASIC DIRECT, LLC
06.0
In Commercial Distribution

  • 00815500020119 ()
  • 10815500020116 ()

  • Length: 70 Millimeter
06.2270B

  • Bone-screw internal spinal fixation system, sterile

nordicMEDIVA - 07090042059077

nordicMEDiVA is a software as a medical device (SaMD) for processing of MR images of the brain. Users will configure analysis pipelines, which are executed automatically when image data is received or manually by a user. The user can choose to send the results to other DICOM nodes for review or use nordicView for their review and export the results to PACS, neuro navigation systems, or other DICOM-compliant modalities. nordicMEDiVA is a server-client solution and can be installed on a local server at the customer's location or in a cloud-based setup. The software is containerized with Docker technology and operates on a GPU-enabled Linux host. This allows customers to manage the server environment themselves or use it as a Software as a Service (SaaS) hosted by NordicImagingLab AS in the cloud. Customers can install the server on physical hardware, virtual machines, or in their own cloud infrastructure. The device comprises a database, DICOM functionality, various APIs, a visualization engine, and medical image analysis modules. The device is not intended for long-term persistent storage of medical diagnostic data. The device incorporates rule-based algorithms for the calculation of metrics from dynamic MRI data. The device does not incorporate AI algorithms based on neural networks. The device connects to other imaging modalities, such as MR scanners, PACS, and surgical navigation systems.
Nordicneurolab AS
2
In Commercial Distribution

  • 07090042059077 ()


  • MRI system application software

VasQ - 07290016063325

External support for vascular access arteriovenous fistulas
LAMINATE MEDICAL TECHNOLOGIES LTD
2
In Commercial Distribution

  • 07290016063325 ()
FG0032

  • Arteriovenous fistula extraluminal mesh-sleeve

Oxevision Sleep system - 50607514500023

Sleep disorder interpretive software, professional-only
OXEHEALTH LIMITED
2
In Commercial Distribution

  • 50607514500023 ()


  • Sleep disorder interpretive software, professional-only

Vital Signs - 50607514500009

Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And Respiratory Rate
OXEHEALTH LIMITED
2
In Commercial Distribution

  • 50607514500009 ()


  • Near-infrared camera vital sign measurement software

MRI Planner - 07350097430017

MRI Planner is a stand alone software product intended to enable a completely MRI only workflow in radiotherapy planning. The MRI Planner software achieves this by analyzing a dedicated MR image and generating a synthetic CT image that can replace the conventional CT in the treatment planning process. In addition, the software also performs automated contouring of risk organs in certain anatomies. In the current version of MRI Planner, synthetic CT generation is supported for the brain, head-neck and pelvis anatomies, whereas automated risk organ contouring is supported for bladder, colon and femoral heads for prostate cancer patients only.
Spectronic Medical AB
2
In Commercial Distribution

  • 07350097430017 ()


  • Radiation therapy software

Sectra Calibration Unit - 07350092810395

The Sectra Calibration Unit consists of calibration holders and markers. The calibration holders are intended to correctly place the calibration markers in relation to the patient during image acquisition. The calibration markers will be visible on the x-ray images and are intended to serve as scaling references. Typical users of the device are trained professionals, for example radiology technicians.
Sectra AB
2
In Commercial Distribution

  • 07350092810395 ()


  • General-purpose diagnostic x-ray phantom, test object
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