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FluoroPerm® 92 (paflufocon A) 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 92 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® 92 rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomers.
FluoroPerm® 92 rigid gas permeable tinted lenses offer a handling aid for locating the lens. These products may be plasma treated.
Paragon Vision Sciences, Inc.
Fluoroperm 92
In Commercial Distribution
- B22204 ()
- Rigid-gas-permeable corrective contact lens, daily-wear
- Rigid-gas-permeable corrective contact lens, extended-wear
The EXOGEN Ultrasound Bone Healing System provides non-invasive therapy for healing non-unions and accelerating time to healing of fresh fractures. EXOGEN is designed both for use with conservatively treated fresh fractures and non-unions, or surgically-treated non-unions. EXOGEN transmits a low-intensity ultrasound signal to the fracture site through coupling gel, with little or no sensation felt by the patient during the treatment. Low-intensity pulsed
ultrasound has been shown in in-vitro and in-vivo studies to stimulate cells to produce growth factors and proteins that are important to bone healing.
The patient administers treatment at home or at work, once daily, for 20 minutes, or as prescribed by a physician. EXOGEN automatically alerts the patient in case of improper application or performance. The EXOGEN Ultrasound Bone Healing System consists of one EXOGEN device, a charger, a gel bottle and strap. The EXOGEN device provides the treatment control circuitry, the battery supply and monitors the operation of the transducer at the fracture site. Thesignal specifications cannot be changed.
BIOVENTUS LLC
71034400
In Commercial Distribution
- M937710344001 ()
71034400
- Bone growth ultrasonic stimulator
- Radiographic image marker, manual
- Skin topical coupling gel
- Personal device holder, single-use
- Noninvasive device battery charger
The Shockwave C2 Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of the heart to the site of an otherwise difficult to treat calcified stenosis, including calcified stenosis that are anticipated to exhibit resistance to full balloon dilation or subsequent uniform coronary stent expansion. The IVL Catheter contains integrated lithotripsy emitters for the localized delivery of acoustic pressure pulse therapy. The lithotripsy technology generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of the IVL Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2 Catheter is available in four (4) sizes: 2.5x12mm, 3.0x12mm, 3.5x12mm, and 4.0x12mm. The Shockwave C2 is compatible with a 6F guiding catheter and extensions, has a working length of 138cm, and shaft depth markers at the proximal end. The catheter is coated with hydrophilic coating to 22.75 cm from the distal tip to reduce friction during device delivery.
Shockwave Medical, Inc.
4.0 x 12mm
In Commercial Distribution
- 00195451000119 ()
- Balloon Proximal Outer Diameter (OD): 0.047 Inch
- Balloon Diameter: 4.0 Millimeter
- Balloon Length: 12 Millimeter
- Catheter Working Length: 138 Centimeter
- Introducer Sheath Compatibility: 6 French
- Guidewire Diameter: 0.014 Inch
- Balloon Nominal (Inflation) Pressure: 6 Atmosphere
- Balloon Rated Burst Pressure: 10 Atmosphere
C2IVL4012
- Intravascular lithotripsy system balloon catheter, coronary
The SpinaLogic is a portable, battery powered, microcontrolled, noninvasive bone growth stimulator indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels. The SpinaLogic is available in one size.
DJO, LLC
Spinalogic
In Commercial Distribution
- 00888912011495 ()
01-207-0007
- Patient-worn bone growth electromagnetic stimulator
The MAG is an electro-mechanical ablation system that utilizes both monopolar and bipolar radio frequency (RF) energy to ablate biological tissue. The MAG can be used with a variety of AtriCure Handpieces to perform cardiac ablations.
ATRICURE, INC.
MAG
In Commercial Distribution
- 10840143900044 ()
- 30840143904473 ()
A001372
- Cardiac radio-frequency ablation system generator
The VisuMax laser keratome is a femtosecond laser. It generates a beam of ultra-short laser pulses which
are guided through the aperture in the treatment objective .
The optical system focuses the laser beam into the corneal tissue.
The VisuMax femtosecond laser is indicated for use in ophthalmic surgery for the creation of corneal incisions in patients undergoing the following treatments:
- In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea
- In patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea
- In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty
- In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting
- Surgery or other treatment requiring initial lamellar resection of the cornea to create tunnels for placement of corneal ring segments.
Additionally under class III:
The VisuMax Femtosecond Laser is indicated for use in small incision
lenticule extraction (SMILE) for the reduction or elimination of
myopia with or without astigmatism
• for spherical refractive error (in minus cylinder format) from -1.00 diopters through -10.00 diopters,
• for cylinder from -0.75 diopters through -3.00 diopters,
• when refraction spherical equivalent is no greater in magnitude than 10.00 diopters,
in patients 22 years of age or older with documentation of stable manifest refraction over the past year as demonstrated by a change in sphere and cylinder of lower or equal 0.50 D in magnitude.
Carl Zeiss Meditec AG
VisuMax
In Commercial Distribution
- 04049471095036 ()
- Weight (basic unit) 470 kg
- Weight (PSS): 250 kg
- Weight (platform): 150 kg
- L x W: 4.00 m x 3.70 m
- Femtosecond ophthalmic solid-state laser system
ISPAN Perfluoropropane (C3F8) is a liquified gas under pressure and is administered by injection into the vitreous cavity. It is Octafluoropropane (C3F8) from the Haloalkanes chemical family. The boiling point is -36.7°C (-34.1°F) and the vapor pressure at 20°C is 100 psig (pounds per square inch gauge). Perfluoropropane is clear and colorless with a faintly sweet odor. ISPAN C3F8 purity: perfluoropropane (Octafluoropropane) 99.8% (minimum), air 1000 ppm (maximum), and perfluoropropene 10 ppm (maximum).
ESCALON MEDICAL CORP.
20 g Cylinder
In Commercial Distribution
- 10860113000109 ()
- 00860113000102 ()
- 20860113000106 ()
TR9089
- Vitreous/aqueous humour replacement medium, intraoperative
The Physician Configuration Device is used to configure the Patient Therapy Controller for proper use with a single Programmable Pump. It can also be used to read historical data and error logs from the Patient Therapy Controller.
Flowonix Medical, Inc.
12861
In Commercial Distribution
- 00810335020181 ()
- Infusion pump programmer
The integrated Backup NO delivery system is a completely independent backup NO generating system that is separate from the main delivery system; it has its own NO generator and gas flow delivery system. Backup NO flow can be delivered to one of two different locations by using the System Selector switch located on the front panel of the LungFit PH system.
When the Selector Switch is turned to “Bagging System” position, the backup NO module turns on and delivers 1 L/min of 220 ppm of NO through a separate internal NO2 filter to the Bagging System connector on the front panel of the LungFit PH system. The Bagging System connector has two tubing fittings: one for connecting to an air/oxygen source through oxygen tubing or equivalent to provide an external flow of air/oxygen and the other to connect to a manual resuscitator for manually ventilating a patient. The 1 L/min NO flow from the backup NO module is added to this air/oxygen flow which dilutes the NO concentration down to therapeutic levels. Final NO concentration will depend on the amount of external flow added; for example, a flow of 10 L/min will provide 20 ppm of NO to the patient.
Beyond Air, Inc.
90005
In Commercial Distribution
- B882900051 ()
- B882900050 ()
- B882900052 ()
- Nitric oxide delivery unit, system-based
The Shockwave C2 Aero Coronary IVL Catheter is a proprietary lithotripsy device delivered through the coronary arterial system of the heart to the site of an otherwise difficult to treat calcified stenosis, including calcified stenoses that are anticipated to exhibit resistance to full balloon dilatation or subsequent uniform coronary stent expansion. Intravascular Lithotripsy (IVL) is an interventional procedure that utilizes a fluid-filled catheter connected to power sources that generate acoustic shock waves; the shock waves modify calcified plaque in coronary arteries. The IVL Catheter contains integrated lithotripsy emitters for the localized delivery of acoustic pressure pulse therapy. The lithotripsy technology generates acoustic pressure pulses within the target treatment site, disrupting calcium within the lesion allowing subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of the IVL Catheter, IVL Connector Cable and IVL Generator. The Shockwave C2 Aero Coronary IVL Catheter is available in four (4) sizes: 2.5x12 mm, 3.0x12 mm, 3.5x12 mm, and 4.0x12 mm. The Shockwave C2 Aero Coronary IVL Catheter is compatible with a 6F guiding catheter, has a working length of 138 cm, and shaft depth markers at the proximal end. The catheter is coated with hydrophilic coating to 22.75 cm from the distal tip to reduce friction during device delivery.
Shockwave Medical, Inc.
4.0x12mm
In Commercial Distribution
- 00195451000621 ()
- Balloon Length: 12 Millimeter
- Balloon Diameter: 4.0 Millimeter
- Balloon Proximal Outer Diameter (OD): 0.047 Inch
- Catheter Length: 138 Centimeter
- Guidewire Compatibility: 6 French
C2AIVL4012
- Intravascular lithotripsy system balloon catheter, coronary