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FluoroPerm® 60 (paflufocon B) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lenses with spherical, aspheric, bifocal or toric anterior and/or posterior; or, bitoric surfaces in clear and tinted versions. FluoroPerm® 60 rigid gas permeable contact lenses for extended wear are available as lathe cut or molded firm contact lenses with spherical or aspheric anterior or posterior surfaces in clear and tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea.
The FluoroPerm® 60 rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomers.
FluoroPerm® 60 rigid gas permeable tinted lenses offer a handling aid for locating the lens. These products may be plasma treated.
Paragon Vision Sciences, Inc.
Fluoroperm 60
In Commercial Distribution
- B22205 ()
- Rigid-gas-permeable corrective contact lens, daily-wear
- Rigid-gas-permeable corrective contact lens, extended-wear
Paragon HDS® (paflufocon B) rigid gas permeable contact lenses for daily wear are available as lathe cut or molded firm contact lenses with spherical, aspheric, bifocal or toric anterior and/or posterior; or, bitoric surfaces in tinted versions. Paragon HDS® rigid gas permeable contact lenses for extended wear are available as lathe cut or molded firm contact lenses with spherical or aspheric anterior or posterior surfaces in tinted versions. The posterior curve is selected so as to properly fit an individual eye and the anterior curve is selected to provide the necessary optical power to correct refractive error. A peripheral curve system on the posterior surface allows tear exchange between the lens and the cornea.
The Paragon HDS® rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomers.
The Paragon HDS® rigid gas permeable tinted lenses offer color enhancement of the eye and a handling aid for locating the lens. These products may be plasma treated.
Paragon Vision Sciences, Inc.
Paragon HDS
In Commercial Distribution
- B22208 ()
- Orthokeratology contact lens
- Rigid-gas-permeable corrective contact lens, daily-wear
- Rigid-gas-permeable corrective contact lens, extended-wear
VALVE FLUSH F/B D/C W/CONNECTOR
The Integra Mishler Dual Chamber Flushing valve, Flat Bottom Design incorporates two separate interior chambers to provide two-way flow control when shunting cerebrospinal fluid (CSF) from the ventricles of the brain. This silicone elastomer flushing valve is available with or without an integral Anti-Siphon Device. The flat bottom configuration eliminates the need for a formal burr hole, provides greater latitude in positioning the flushing valve and allows the ventricular catheter to be revised without disturbing the flushing valve. Due to the dual chamber feature, the proximal and distal catheters may be flushed separately or simultaneously. The flow of CSF from the ventricular catheter is controlled by a miter valve located on the vertical chamber divider. This valve is designed to open under a medium positive ventricular pressure and close under a negative pressure. The flushing valve dome is marked with an arrow to indicate the CSF flow direction. The flange overlying the skull contains sutural holes to facilitate securing the device to the periosteum.
Integra Lifesciences Corporation
NL8500312
Not in Commercial Distribution
- 10381780072256 ()
- M269NL85003121 ()
- Inlet Integral Connector: 1.1 mm ID x 1.9mm OD; Outlet Integral Connector: 1.1 mm ID x 1.9 mm OD (all dimensions nominal)
NL8500312
- Cerebrospinal fluid shunt valve
Paragon CRT® Contact Lenses are manufactured from Paragon HDS® (paflufocon B), Paragon CRT® 100 Contact Lenses and Paragon CRT Dual Axis® Contact Lenses are manufactured from Paragon HDS® 100 (paflufocon D). The lenses are designed to have congruent anterior and posterior surfaces each consisting of three zones: the central spherical zone, a mathematically designed sigmoidal corneal proximity “Return Zone” and a non-curving “Landing Zone”.
The lens design also includes a convex elliptical edge terminus smoothly joining the anterior and posterior surfaces.
Paragon CRT Dual Axis® Contact Lenses for Corneal Refractive Therapy 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 Refractive Therapy are available as lathe cut firm contact lenses with blue, red, yellow, violet and green tints. The tinted lenses depending on the tint color contain 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 CRT Dual Axis
In Commercial Distribution
- B22219 ()
- Orthokeratology contact lens
Until the development of the Smell Identification Test™, also known as the University of Pennsylvania Smell Identification Test (UPSIT), no convenient means for subjectively assessing smell function was generally available. By incorporating microencapsulation technology and sound psychometric principles into a simple test format, the Smell Identification Test™ filled this void. Although this test was initially designed to provide only a first-step olfactory “screening” function, it became quite clear early on that the test was much more broadly useful than first envisioned and had applicability in numerous clinical, laboratory, and industrial settings. Indeed, the Smell Identification Test™ was found to be more reliable and to correlate more closely in the clinical setting with patient complaints and other indices of dysfunction than more traditional threshold and suprathreshold psychophysical methods.
The Smell Identification Test consists of four envelope-sized booklets, each containing ten “scratch & sniff ” odorants. The odorants are embedded in 10- to 50-um urea-formaldehyde polymer microencap- sules fixed in a proprietary binder and positioned on brown strips at the bottom of the test booklets. The stimuli are released by scratching strips with a pencil tip in a standardized manner. Above each odorant strip is a multiple-choice question with four alternative responses. For example, one of the items reads: “This odor smells most like: a) chocolate; b) banana; c) onion; or d) fruit punch.” The test is forced-choice; i.e., the subject is required to mark one of the four alternatives even if no smell is perceived.
Sensonics, Inc.
SITT
In Commercial Distribution
- G051SITT0 ()
- Olfactory test stick
Light weight (~2.5 Kg.) and portable therapeutic medical laser device (measuring ~258.65mm x 238.43m x 88.86mm) disc shaped, indicated for temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions. The noninvasive laser treatments (Continuous Wave - CW power 28W and Intense Super Pulse - ISP power 30W) are in the form of non-ionizing radiation in which the invisible light wave doses (810nm +/- 10nm, 915nm +/- 10nm, 980nm +/- 10nm) and visible light wave aiming beam (650nm +/- 20nm) are not cumulative and do not create changes in cellular DNA. The presence of a temperature gradient generates an increased local blood circulation through the tissue to reduce inflammation and pain and to enhance the rate of tissue repair. The laser energy increases circulation, drawing water, oxygen, and nutrients to the target area. The increase in circulation provides a healing environment that reduces inflammation, swelling, muscle spasm, stiffness, and pain. The increased circulation of blood speeds up the process of respiratory cellular activity by stimulating an increase in hemoglobin and nutrients at the target cell and a decrease in cellular carbon dioxide and lactic acid waste. The laser light therapy promotes the transport of nutrients across the cell membrane to aid in the natural repair mechanism of the target cells by stimulating an increase in production of Adenosine Triphosphate (ATP) energy in the cell. The increase in ATP energy and the decrease in waste enhances cellular function and tissue repair.
SUMMUS MEDICAL LASER, LLC
P4H
In Commercial Distribution
- B679SLP4H0 ()
SLP4H
- Musculoskeletal/physical therapy laser, professional