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LimFlow Crossing Stent Graft (4.0-5.5 mm x 60 mm). The LimFlow Crossing Stent Graft is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
RGS-40060-US-24
In Commercial Distribution
- 00850041730172 ()
- Arteriovenous endovascular stent-graft
LimFlow Crossing Stent Graft (3.5-5.5 mm x 60 mm). The LimFlow Crossing Stent Graft is indicated for patients who have chronic limb-threatening ischemia with no suitable endovascular or surgical revascularization options and are at risk of major amputation.
Limflow Inc.
RGS-35060-US-24
In Commercial Distribution
- 00850041730165 ()
- Arteriovenous endovascular stent-graft
The XVIVO Perfusion System (XPS™) is indicated for use in flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the ex-vivo function of the lungs can be reas-sessed for transplantation.
Xvivo Perfusion AB
19030
In Commercial Distribution
- 07350069520104 ()
19030
- Lung donor-organ preservation/evaluation system
The Test Impedance Tool is used by system administrator when performing measurement accuracy tests with the Nevisense. A measurement accuracy test should be performed once a month, to ensure that all Nevisense examinations will present correct measurement data.
Scibase AB
590-0002
In Commercial Distribution
- 07350094440101 ()
590-0002
- Neoplasm electrical impedance spectrometer
Hologic Clarity HD® (high resolution tomosynthesis) is a software driven digital breast tomosynthesis 3(D) imaging feature intended to improve image resolution on tomosynhesis slices and synthesized 2D images that will enhance image quality and user experience.
Hologic, Inc.
CLARITY HD SOFTWARE
In Commercial Distribution
- 15420045507272 ()
SW-04756
- Stationary mammographic x-ray system, digital
The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.
Inspire Medical Systems, Inc.
900-017-001
In Commercial Distribution
- 00855728005925 ()
2580
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.
Inspire Medical Systems, Inc.
900-008-053
In Commercial Distribution
- 00855728005611 ()
2500
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.
Inspire Medical Systems, Inc.
900-008-003
In Commercial Distribution
- 00855728005598 ()
2500
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.
Inspire Medical Systems, Inc.
900-008-051
In Commercial Distribution
- 00855728005253 ()
2500
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The sleep remote is an external device that is about the size of a cell phone and is used by the patient to activate the Inspire system before they go to sleep. The patient places the remote over the implanted IPG site, and uses push buttons on top of the programmer to: a.) turn the therapy ON or OFF, b.) temporarily suspend therapy, or c.) make adjustments to the stimulation strength (within limits set by the physician). The patient’s sleep remote also allows patients to check the status of the IPG battery. There are both visual and audio indicators that provide information on the IPG status (therapy ON/OFF, therapy paused, stimulation level and battery status). The Inspire sleep remote will only communicate with the Inspire IPG.
Inspire Medical Systems, Inc.
900-008-000
In Commercial Distribution
- 00855728005222 ()
2500
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system