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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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Trigon - 00810005669436

Trigon CC Wedge Case Assembly. The Trigon HA Stand-Alone Wedge Fixation System is a family of wedges used for angular correction of small bones of the foot. The HA PEEK wedges w/ tantalum markers are provided in multiple footprint and thickness designs, and the titanium bone screws are available in multiple lengths to accommodate variations in patient anatomy.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
CC-1001C-100
Not in Commercial Distribution

  • 00810005669436 ()


  • Surgical instrument/implant rack

Trigon - 00810005669368

Trigon CC Wedge Case Assembly. The Trigon HA Stand-Alone Wedge Fixation System is a family of wedges used for angular correction of small bones of the foot. The HA PEEK wedges w/ tantalum markers are provided in multiple footprint and thickness designs, and the titanium bone screws are available in multiple lengths to accommodate variations in patient anatomy.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-1001C-300
In Commercial Distribution

  • 00810005669368 ()


  • Surgical instrument/implant rack

Surearly SMART - 08809408863499

Surearly SMART is a self-testing in-vitro diagnostic device that displayed qualitative or semi-quantitative results from a test stick that detects various hormones such as hCG, LH, FSH, etc. in human urine. The firmware-driven Surearly SMART measures the color degree of the test stick using optical methods according to the visible light reflectance. The measured data is transmitted to the Surearly SMART App via Bluetooth, and the analyzed results are transmitted back to the Surearly SMART and displayed.
Sugentech Inc._Osong Branch
Surearly SMART (SSMD001E)
In Commercial Distribution

  • 08809408863499 ()


  • Immunoassay reagent vehicle reader IVD

Home Vision Monitor® - 00860004152705

The Home Vision Monitor® Model 0005 is a vision function test provided as a downloadable app on to the user’s supplied cell phone or tablet. The Home Vision Monitor® Model 0005 implements a shape discrimination hyperacuity (SDH) vision test which allows patients to perform their own vision test at home. If a significant worsening of vision function is detected the physician will be notified and provided access to the vision self-test results so that they can decide whether the patient needs to be seen sooner than their next already scheduled appointment.
VITAL ART AND SCIENCE, LLC
Model 0005
Not in Commercial Distribution

  • 00860004152705 ()


  • Vision testing/training chart

NA - 04055207058848

CORE.PORTAL Establishes the connection between the intra-operative networks and the hospital-wide IT systems.Provides various services centrally in all operating rooms. Included are: Installation service Receiving and forwarding of patient lists by means of DICOM WORKLIST. Receiving and forwarding of images and videos by means of DICOM STORE. Intraoperative management of recorded images and videos using MEDIA ARCHIVE APP. A server, which provides the virtual environment with the ESXi operating system, is required for installation. The server hardware is not part of the Richard Wolf portfolio and must be provided by customers on their own.
Richard Wolf GmbH
5597101
In Commercial Distribution

  • 04055207058848 ()
5597101

  • Operating room audiovisual data/device management system application software

BCL-MS - 00199284085701

BeCareLink MS is a mobile medical application designed to assist individuals diagnosed with Multiple Sclerosis (MS) in tracking, assessing, and managing their condition. The application allows users to complete periodic assessments that measure various neurological functions, including cognitive processing, motor coordination, and speech. These assessments are designed to provide longitudinal data regarding disease progression and symptom variability. The app stores user responses and performance data, which can be reviewed by healthcare professionals to aid in clinical decision-making. The software does not provide a diagnosis or treatment recommendation but functions as a patient management and monitoring tool.
BeCare Link, LLC
MS 2.1
In Commercial Distribution

  • 00199284085701 ()
BCL-MS

  • Self-care monitoring/reporting software

Trigon - 00814008029785

Instrument: CC Wedge Inserter. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-1001T-CCI
In Commercial Distribution

  • 00814008029785 ()


  • Orthopaedic inorganic implant inserter/extractor, reusable

Philips - 00884838118782

BREAST 7 BIOPSY PACK, 1.5T contains - 3 Grid Immobilization Plate LBS M-L; 3 Pillar Immobilization Plate LBS M-L; MRI Needle Block 14G; MRI Needle Block 16G; 3 Needle Hub Assembly; MRI Needle Block 12G; MRI Needle Block 18G; MRI Needle Sleeve 12G; MRI Needle Sleeve 18G; MRI Needle Sleeve 14G; 3 Grid Immobilization Plate LBS; 3 Pillar Immobilization Plate LBS C-C; 2 Fiducial Marker Sleeve Assembly; MRI Needle Sleeve 16G; Fiducial Marker Grid Block Assembly; 2 Needle Block Holder.
Philips Medical Systems Nederland B.V.
989603110736
In Commercial Distribution

  • 00884838118782 ()


  • Needle guide, single-use
  • Needle guide, reusable

Trigon - 00810005669429

Instrument: CC Wedge 14mm Trial. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-2514T-CC
In Commercial Distribution

  • 00810005669429 ()

  • 14mm, Thick
  • Width: 25 Millimeter


  • Orthopaedic inorganic implant inserter/extractor, reusable

Trigon - 00810005669412

Instrument: CC Wedge 12mm Trial. The Trigon HA Stand-Alone Wedge Fixation System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot, such as: • Cotton ( opening wedge) Osteotomies of the Medial Cuneiform • Evans Lengthening Osteotomies • Subtalar Fusion • First Metatarsal-Cuneiform Lengthening Arthrodesis • Calcaneocuboid Arthrodesis The Trigon HA wedges are intended for use with ancillary fixation. The Trigon HA Stand-Alone Wedge Fixation System is not intended for use in the spine.
NVISION BIOMEDICAL TECHNOLOGIES, INC.
WD-2512T-CC
In Commercial Distribution

  • 00810005669412 ()

  • 12mm, Thick
  • Width: 25 Millimeter


  • Orthopaedic inorganic implant inserter/extractor, reusable
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