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Training electrodes, used for Nevisense training and qualification. Each electrode is to be used only on intact, healthy skin on a single person in a single training session. Each electrode can be used up to 50 times. The reason for the higher number (i.e., 50, as compared with 20 for the examination electrode) is that these electrodes are used for training and qualification purposes only.
Scibase AB
131-0008
In Commercial Distribution
- 07350094440217 ()
131-0008
- Neoplasm electrical impedance spectrometer electrode array
Genius AI® is a computer-aided detection and diagnosis (CADe/CADx) software device intended to be used with compatible digital breast tomosynthsis (DBT) systems to identify and mark regions of interest including soft tissue densities (masses, architectural distortions, and assymetries) and calcifications in DBT exams from compatible DBT systems and provide confidence scores that offer assessment for Certainty of Findings and a Case Score.
Hologic, Inc.
GENIUS AI DETECTION SOFTWARE
In Commercial Distribution
- 15420045512474 ()
ASY-15431
- Stationary mammographic x-ray system, digital
Paragon RG-4 contact lenses are manufactured from Paragon HDS® 100. The reverse geometry design has a posterior surface consisting of four zones: The central spherical or aspheric zone, an annular “Reverse Zone(s)”surrounding the central zone with a curvature steeper (shorter radius) than the central zone, an “Alignment Zone(s)” generally paralleling the underlying corneal surface and peripheral curve(s) with a radius selected to create “edge lift” to promote tear flow under the lens and avoid impingement of the peripheral curve on the cornea.
The lens design also includes a “rounded” edge terminus extending from the anterior to the posterior surfaces to promote comfort.
Paragon RG-4 Contact Lenses for Corneal Reshaping are to be worn overnight with removal during all or part of each following day. The material is a thermoset fluorosilicone acrylate copolymer derived primarily from siloxane acrylate, trifluoroethyl methacrylate and methylmethacrylate with a water content of less than 1%. These contact lenses for corneal reshaping are available as lathe cut firm contact lenses with blue, green, red and yellow tints containing D&C Green No. 6, D&C Red No. 17 and Perox Yellow No. 9 (4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one). These products may be plasma treated.
Paragon Vision Sciences, Inc.
Paragon RG-4
In Commercial Distribution
- B22220 ()
- Orthokeratology contact lens
The Model 1680 Torque Wrench is a sterile standard surgical wrench provided for use during the implant procedure to tighten the set screws that secure the leads to the Rechargeable Neuroregulator.
Reshape Lifesciences Inc.
1680
Not in Commercial Distribution
- 00857334004248 ()
- Length: 1.685 Inch
- Outer Diameter: 0.218 Inch
1680
- Surgical torque wrench, reusable
The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. Cordella Sensor Delivery Kit consists of the Cordella PA Sensor and Delivery System which are components of the Cordella Pulmonary Artery Sensor System.
Cordella PA Sensor
The Cordella Sensor is a small implant that resides permanently in the patient’s right pulmonary artery. The Cordella Sensor does not contain batteries or active electrical components. The Cordella Sensor is not made with natural rubber latex.
Delivery System
The Delivery System is a catheter with a pre-loaded Cordella Sensor at the distal end and is used to implant the Cordella Sensor into the right pulmonary artery. The Delivery System comprises a stability sheath, torque catheter, handle, torque luer, and side port. Implantation of the Cordella Sensor using the Delivery System is designed to be performed during right heart catheterization through venous access. The Stability Sheath contains a marker band at the distal end to aid in visualization under fluoroscopy. The Delivery System is not made with natural rubber latex.
Endotronix, Inc.
100303-05
In Commercial Distribution
- 00850008997006 ()
- Implantable pulmonary artery pressure monitoring system
The Shockwave Medical Inc. IVL Generator and Connector Cable provides power and exchanges data via a Connector Cable to the IVL Catheters, which deliver localized lithotripsy-enhanced balloon dilatation of calcified stenotic arteries.
Shockwave Medical, Inc.
825Dx
In Commercial Distribution
- 00195451000355 ()
IVLGCCDX
- Intravascular lithotripsy system generator
The Pillar Variant Analysis Toolkit or PiVAT is an analytical software that comes on a preloaded workstation that is used to analyze sequencer data to generate applicable reports for the oncoReveal CDx
Pillar Biosciences, Inc.
SFW-2012 2.0
In Commercial Distribution
- 00860001218275 ()
SFW-2012
- Colorectal cancer genotyping IVD, kit, nucleic acid technique (NAT)
Selenia® Dimensions® digital mammography system is a mammographic system used for capturing digital x-ray images of the breast. The Digital Breast Tomosynthesis imaging uses high-resolution Tomosynthesis, known as Clarity HD.
Hologic, Inc.
ASY-11748-CHD
In Commercial Distribution
- 15420045511897 ()
ASY-11748-CHD
- Stationary mammographic x-ray system, digital
A Kit for 10 Neuro treatments (Master Treatment Kit for 3.0T (SIEMENS) Type 1.1 NonCE/FDA)
Kit content:
Part Description
SET001047 EXABLATE NEURO PATIENT TREATMENT KIT 3.0T SI (5) X 2 units
INSIGHTEC LTD
SET001104 Master Treatment Kit for 3.0T (SIEMENS) Type 1.1 NonCE/FDA
In Commercial Distribution
- 07290015461900 ()
SET001104
- Therapeutic oncological/gynaecological ultrasound system
A Kit for 10 Neuro treatment (Master Treatment Kit for 1.5T (SIEMENS) Type 1.1 NonCE/FDA).
Kit content:
Part Description
SET001046 EXABLATE NEURO PATIENT TREATMENT KIT 1.5T SI (5) X 2 units
INSIGHTEC LTD
SET001103 Master Treatment Kit for 1.5T (SIEMENS) Type 1.1 NonCE/FDA
In Commercial Distribution
- 07290015461894 ()
SET001103
- Therapeutic oncological/gynaecological ultrasound system