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Instrument: CC Wedge 8mm 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-2508T-CC
In Commercial Distribution
- 00810005669399 ()
- 8mm, Thick
- Width: 25 Millimeter
- Orthopaedic inorganic implant inserter/extractor, reusable
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
Instrument: Trigon CC Wedge Graft Packing Block. 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-1000T-CGPB
In Commercial Distribution
- 00810005669382 ()
- Surgical tissue compression device
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or forhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=1301830# hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
923C
In Commercial Distribution
- 00745129188863 ()
- Pressure,30-40 mmHg
923CSSM99
- Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fithttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=1301826#ted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device.
SIGVARIS INC
923C
In Commercial Distribution
- 00745129188849 ()
- Pressure,30-40 mmHg
923CMSM99
- Compression/pressure sock/stocking, single-use
A tube-like garment made of elastic material(e.g., circular knit nylon and spandex yarns) that exerts a pressure upon the limb upon which it is fitted (typically a leg, but some types may be used on an arm), primarily to improve venous return to treat/prevent one or more disorders of circulation(e.g. oedema, deep vein thrombosis (DVT), varicosis). It might be referred to as a compression stocking or flight sock and may be intended to apply a graduated pressure across a limb,however it is not intended to support an injured joint. It is normally available (non-prescription) over-the-counter (OTC) for home-use and/or for hospitalized or institutionalized patients. This is a reusable device. https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=1301808#
SIGVARIS INC
923C
In Commercial Distribution
- 00745129188832 ()
- Pressure,30-40 mmHg
923CLLM99
- Compression/pressure sock/stocking, single-use
Alleye® is a vision function test provided on a commercially available mobile phone. Alleye® implements an alignment hyperacuity task which helps patients with age-related macular degeneration (AMD) to assess their vision at home. This allows the timely detection of significant changes in vision function, enabling the regular monitoring of the disease progression and/or verifying the efficacy of ongoing treatments. Alleye is a digital technology, consisting of two different items: a mobile app for patients and a web interface for eye care professionals. Principle of Operation The test consists of 12 tasks that are performed on the user’s mobile phone. For each task, two dots are placed at each extremity of an invisible axis. A third dot is placed between these two dots, 40 pixels above or 40 pixels below the axis. The test consists in aligning the three dots by moving the dot in the middle. A single click on the up and down buttons moves the dot by 0.3 pixels up or down, respectively. If the patient maintains their finger on the buttons, the dot keeps moving. When it reaches a limit of 50 pixels away from its ideal position on the axis, the dot automatically stops. Once the user is satisfied with the position of the middle dot, they confirm it by tapping the circle button between the two arrow buttons. Overall, the patient must perform three alignments on four different axes (horizontal, vertical, oblique upper left / lower right, and oblique upper right / lower left). The test is performed on one eye only. The eye that is not being tested must be covered before starting the test. The TRAINING mode allows the patient to learn how to use the app, without recording the score results. To start the test, the patient must select TEST, and then select the eye (RIGHT or LEFT) to be tested. The Alleye tasks will proceed until COMMENT ON TEST appears on the screen. The patient can select REPEAT to start the test again, or DONE to save the test and display the results.
OCULOCARE medical AG
3.2.12
In Commercial Distribution
- EOMA32120 ()
- Vision self-testing software
REA108 recognizes human CD197 which is a chemokine receptor with a C-C motif that mediates homing of T cells to secondary lymphoid organs via high endothelial venules (HEV) and is also known as CCR7. For example, naive T cells migrate very efficiently through lymph nodes using the adhesion molecules L-selectin, CD62L, and CCR7. Ligands for CCR7, e.g. CCL19, are expressed by the HEV of secondary lymphoid organs, by parenchymal cells within T cell zones of lymph nodes, and by endothelial cells at the openings of lymphatic vessels within peripheral tissues. Expression of CCR7 and the CD45RA isoform distinguishes three subsets of T cells: naive T cells (CCR7+CD45RA+), central memory T cells (CCR7+ CD45RA-), and effector memory T cells (CCR7- CD45RA-).
Miltenyi Biotec B.V. & Co. KG
170-081-034
In Commercial Distribution
- 04049934134258 ()
- Assay development analyte-specific reagent IVD
REA546 recognizes the human CD197 antigen, which is also known as CCR7. CD197 is a chemokine receptor with a C-C motif that mediates homing of T cells to secondary lymphoid organs via high endothelial venules (HEV). For example, naive T cells migrate very efficiently through lymph nodes using the adhesion molecules L-selectin, CD62L, and CCR7. Ligands for CCR7, e.g. CCL19, are expressed by the HEV of secondary lymphoid organs, by parenchymal cells within T cell zones of lymph nodes, and by endothelial cells at the openings of lymphatic vessels within peripheral tissues. Expression of CCR7 and the CD45RA isoform distinguishes three subsets of T cells: naive T cells (CCR7+CD45RA+), central memory T cells (CCR7+ CD45RA-), and effector memory T cells (CCR7- CD45RA-).
Additional information: Clone REA546 displays negligible binding to Fc receptors.
Miltenyi Biotec B.V. & Co. KG
170-081-083
In Commercial Distribution
- 04049934133763 ()
- Assay development analyte-specific reagent IVD
MyNotifiRX: Is a Bluetooth wearable device that interacts with a patient’s smart phone via an app (iOS or android). All data is sent by wifi to a HIPAA controlled server for real time or accumulated time review by the provider. MyNotifiRX can be used to meet the rehabilitation needs of any extremity after injury. It can be used both pre and post-operatively to meet a patient’s rehabilitation needs. It is designed for acute or chronic use especially in patients at high risk for falls. As an added feature it is designed with a fall detection algorithm to alert designated care givers in the case of an emergency independent of a patient’s ability to respond.
It is designed with two functions.
1) In patients who are evaluated to be at risk for falls, MyNotifi can act as a Fall protection device and monitor. It has a built in algorithm to detect when a possible fall occurs and alerts those that the wearer has designated that an issue has occurred. It is also imbedded with the OTAGO exercise protocol https://www.apta.org/PTinMotion/NewsNow/?blogid=10737418615&id=10737430053 ) which is clinically proven to help prevent falls by improving balance. Long term remote monitoring of patients to assist, adjust, advance or correct exercise regimen is possible. Even more important, it can serve as a means to catch early deterioration of function and signal the need for intervention before an accident occurs.
2) With its magnetic strip and extension band, it can be placed on any extremity to record an exercise regimen programmed by the provider. There is a library of over 40 APTA exercises (attach sheet) that can be selected.
It is recommended for use in upper extremity patients for both nonoperative and post-operative rehabilitation. MyNotifi is best suited in the lower extremity for the rehab of non surgical patients. The addition of a monitor to measure heart rate and blood oxygenation during exercise adds to patient safety and serves as a measure of physical exertion during
MEDHAB, LLC
Version 2
In Commercial Distribution
- 00850023296023 ()
MyNotifi RX - small
- Bed/chair occupant movement pressure/vibration sensor