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The Model 3028 IPG contains electronics and a battery that are sealed inside a titanium case. The IPG is implanted subcutaneously, below the clavicle in the upper chest, and connect to the stimulation lead and sensing lead. The Model 3028 does not contain any software or firmware. All functions including the telemetry and algorithm have been designed into the hardware of the IPG. The algorithm synchronizes stimulation of the hypoglossal nerve with respiration signals. The IPG processes the same dynamic range of pressure signals (2-48 cmH2O) in order to account for pressure reading variability. Based on typical settings from the STAR pivotal trial, the longevity of the Model 3028’s battery will average 10 years although the device is smaller than the currently approved version (Model 3024). In addition the Model 3028 IPG will allow patients to safely undergo magnetic resonance imaging (MRI) under specified conditions.
Inspire Medical Systems, Inc.
900-007-003
In Commercial Distribution
- 10855728005465 ()
3028
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
Paragon Z CRT Dual Axis contact lenses are manufactured from Menicon Z® (tisilfocon A). 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 Z 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 lens material (tisilfocon A) is a thermoset copolymer derived from fluoro-methacrylate and siloxanylstyrene bound by crosslinking agents. The lenses for Corneal Refractive Therapy are available as lathe cut firm contact lenses with a light blue tint. The blue tinted lens contains D&C Green No. 6. A UV absorber (Benzotriazol) is added as an additive during the manufacturing process.
Paragon Vision Sciences, Inc.
Paragon Z CRT Dual Axis
In Commercial Distribution
- B22222 ()
- Orthokeratology contact lens
Paragon Z CRT contact lenses are manufactured from Menicon Z® (tisilfocon A). 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 Z CRT Contact Lenses for Corneal Refractive Therapy are to be worn overnight with removal during all or part of each following day. The lens material (tisilfocon A) is a thermoset copolymer derived from fluoro-methacrylate and siloxanylstyrene bound by crosslinking agents. The lenses for Corneal Refractive Therapy are available as lathe cut firm contact lenses with a light blue tint. The blue tinted lens contains D&C Green No. 6. A UV absorber (Benzotriazol) is added as an additive during the manufacturing process.
Paragon Vision Sciences, Inc.
Paragon Z CRT
In Commercial Distribution
- B22221 ()
- Orthokeratology contact lens
The intended purpose of the Fractured Abutment / Abutment Screw kit is, by an Integrum certified physician to perform extraction of a fractured Abutment remnant in the Fixture of the OPRA™ Implant, and the extraction of a femur fractured Abutment Screw when the fracture has occurred in one of the threads of the OPRA™ Implant Abutment screw.
T-Handle 5mm
Socket M9
Guide Pin Rescue
Drill Bit Holder
Drill / Torx Guide
Allen Key 2.5 mm
Integrum AB
2533
In Commercial Distribution
- 07340152102027 ()
- Internal-external leg prosthesis osseointegration bar
Magnetic Tracer 10 Vials each containing 2ml of Magtrace. Magtrace is a magnetic tracer intended and calibrated for use with the Sentimag device only as part of an overall system to mark and locate lymph nodes in cancer patients prior to their surgical removal. Intended to be injected into interstitial tissue only in proximity to a tumor to facilitate its migration to sentinel lymph nodes for their subsequent localization by the Sentimag magnetometer.
ENDOMAGNETICS LTD
MTVC10001
In Commercial Distribution
- 15060391210244 ()
- Magnetic nanoparticle tracer
The Model 3024 Inspire II IPG contains electronics and a battery that are sealed inside a titanium case. The IPG is implanted subcutaneously below the clavicle in the upper chest, and connects to the stimulation lead and sensing lead.
The IPG has multiple programmable parameters that can be adjusted for a particular patient. Adjustments may be made to the sensing circuits to vary the timing of stimulation pulses and to the stimulation circuits to adjust the energy and duration of stimulation pulses. These adjustments provide the ability to optimize the opening of the upper airway. Based on typical settings from the STAR pivotal trial the longevity of the IPG’s battery will average 10 years.
The Model 3024 IPG was originally developed by Medtronic and utilizes the same platform as Medtronic’s Itrel® 3 IPG which is FDA approved for other neurostimulation therapies. Figure 9 provides a photograph of the Model 3024 IPG.
Inspire Medical Systems, Inc.
900-003-020
In Commercial Distribution
- 00855728005437 ()
3024
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 3024 Inspire II IPG contains electronics and a battery that are sealed inside a titanium case. The IPG is implanted subcutaneously below the clavicle in the upper chest, and connects to the stimulation lead and sensing lead.
The IPG has multiple programmable parameters that can be adjusted for a particular patient. Adjustments may be made to the sensing circuits to vary the timing of stimulation pulses and to the stimulation circuits to adjust the energy and duration of stimulation pulses. These adjustments provide the ability to optimize the opening of the upper airway. Based on typical settings from the STAR pivotal trial the longevity of the IPG’s battery will average 10 years.
The Model 3024 IPG was originally developed by Medtronic and utilizes the same platform as Medtronic’s Itrel® 3 IPG which is FDA approved for other neurostimulation therapies. Figure 9 provides a photograph of the Model 3024 IPG.
Inspire Medical Systems, Inc.
900-003-015
In Commercial Distribution
- 00855728005024 ()
3024
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 2502 Clinician Programmer (CP) is a non-sterile external component that consists of a commercially available laptop computer configured with customized software. The CP connects to the Mobile Charger with a custom Programmer Cable. The CP enables the clinician to enter and modify therapy parameters and therapy schedule in the Rechargeable Neuroregulator. The graphical user interface of the CP allows the clinician to monitor system performance and patient compliance. The CP also provides access to the Instructions for Use manuals.
Reshape Lifesciences Inc.
2502
Not in Commercial Distribution
- 00857334004354 ()
2502
- Vagus nerve electrical stimulation system programmer
The Prometra II Programmable Pump is a sterile, battery-operated, teardrop-shaped implantable, programmable infusion pump, with a rigid titanium housing and flow controller system, which dispenses infusate into the intrathecal space through an implanted intrathecal catheter. To help increase safety, the Prometra II Pump incorporates a safety valve (flow-activated valve or FAV) that will shut off drug flow to the patient in the event a high flow rate occurs, such as during an MRI. All functions of the system (e.g., dosing) are controlled externally using a hand-held, battery-operated programmer. The Prometra II Pump contains a metal bellows drug reservoir with a capacity of 20 milliliters (mL). The reservoir propellant is stored within the rigid housing surrounding the bellows and provides the driving pressure for the pump. The driving pressure on the reservoir forces the infusate through an outlet filter (0.22 pm), and into an electronically controlled flow metering valve-accumulator subsystem. The Infumorph passes from the flow metering subsystem, into the catheter access port then into the catheter for delivery to the intrathecal space.
Flowonix Medical, Inc.
13827
In Commercial Distribution
- 00810335020228 ()
- Implantable intrathecal infusion pump, programmable
The Patient Therapy Controller (PTC) is a handheld touchscreen device, which allows a patient to initiate a pre-configured supplemental bolus of medication from their implanted Programmable Pump. The patient requests a bolus by pressing the Rx button on the PTC and then placing it over their implanted pump. The Patient Therapy Controller communicates with the implanted pump initiating the supplemental bolus delivery. The settings for the bolus delivery are programmed into the Patient Therapy Controller by a healthcare certified professional (HCP) using the Configuration Device.
Flowonix Medical, Inc.
12860
In Commercial Distribution
- 00810335020174 ()
- Infusion pump programmer