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No Description
MEDINOL LTD.
LUN250R20US
Not in Commercial Distribution
- 07290107013550 ()
- Lumen/Inner Diameter: 2.5 Millimeter
- Length: 20 Millimeter
- Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
No Description
MEDINOL LTD.
LUN250R17US
Not in Commercial Distribution
- 07290107013543 ()
- Lumen/Inner Diameter: 2.5 Millimeter
- Length: 17 Millimeter
- Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
No Description
MEDINOL LTD.
LUN250R12US
Not in Commercial Distribution
- 07290107013529 ()
- Lumen/Inner Diameter: 2.5 Millimeter
- Length: 12 Millimeter
- Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
XIENCE Skypoint™ Everolimus Eluting Coronary Stent System 2.75 mm x 48 mm / Rapid-Exchange
ABBOTT VASCULAR INC.
1804275-48
In Commercial Distribution
- 08717648231278 ()
- Stent Length: 48.0000 Millimeter
- Stent Diameter: 2.7500 Millimeter
1804275-48
- Drug-eluting coronary artery stent, non-bioabsorbable-polymer-coated
The Model 2740 physician programmer is designed for use by a physician to non-invasively interrogate and program the IPG. It is the only component in the Inspire system that contains software. This programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates with the IPG through the skin via short-range radio-frequency (RF) telemetry; telemetry communication allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician programmer tablet. The physician programmer has the capability to monitor respiratory waveforms, program stimulation modes, adjust stimulation parameter values, and store waveforms and settings. This data can also be printed via a wireless Bluetooth link to a commercial printer.
Inspire Medical Systems, Inc.
900-004-031
In Commercial Distribution
- 00855728005109 ()
2740
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 2740 physician programmer is designed for use by a physician to non-invasively interrogate and program the IPG. It is the only component in the Inspire system that contains software. This programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates with the IPG through the skin via short-range radio-frequency (RF) telemetry; telemetry communication allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician programmer tablet. The physician programmer has the capability to monitor respiratory waveforms, program stimulation modes, adjust stimulation parameter values, and store waveforms and settings. This data can also be printed via a wireless Bluetooth link to a commercial printer.
Inspire Medical Systems, Inc.
900-004-021
In Commercial Distribution
- 00855728005093 ()
2740
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The Model 2740 physician programmer is designed for use by a physician to non-invasively interrogate and program the IPG. It is the only component in the Inspire system that contains software. This programmer consists of a tablet computer and a telemetry cable. The telemetry head communicates with the IPG through the skin via short-range radio-frequency (RF) telemetry; telemetry communication allows the physician to noninvasively interrogate and program the IPG. The telemetry head is powered by a wall outlet connection and wirelessly communicates (via wireless Bluetooth link) with the physician programmer tablet. The physician programmer has the capability to monitor respiratory waveforms, program stimulation modes, adjust stimulation parameter values, and store waveforms and settings. This data can also be printed via a wireless Bluetooth link to a commercial printer.
Inspire Medical Systems, Inc.
900-004-001
In Commercial Distribution
- 00855728005055 ()
2740
- Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system
The therascreen FGFR RGQ RT-PCR Kit is a real-time, reverse transcription PCR test for the qualitative detection of two point mutations in exon 7 [p.R248C (c.742C>T), p.S249C (c.746C>G)], two point mutations in exon 10 [p.G370C (c.1108G>T) and p.Y373C (c.1118A>G)] and two fusions (FGFR3-TACC3v1 and FGFR3-TACC3v3) in the fibroblast growth factor receptor 3 (FGFR3) gene in RNA samples derived from formalin-fixed paraffin-embedded (FFPE) urothelial tumor tissue. The test is indicated for use as an aid in identifying patients with cases of urothelial cancer (UC) which harbor these alterations and are therefore eligible for treatment with BALVERSA™ (erdafitinib).
Specimens are processed using the RNeasy DSP FFPE Kit for manual sample preparation followed by reverse transcription and then automated amplification and detection on the Rotor-Gene Q MDx (US) instrument.
QIAGEN GmbH
2
In Commercial Distribution
- 04053228043560 ()
874721
- Fibroblast growth factor receptor (FGFR) gene mutation IVD, kit, nucleic acid technique (NAT)
LungFit PH Product Description
The LungFit PH System generates nitric oxide (NO) from room air and delivers it to a mechanical ventilator breathing circuit in a controlled concentration from 0.1 to 80 ppm NO. The attached nitric oxide delivery module (NDM) measures the gas flow in the ventilator breathing circuit and delivers a controlled flow of nitric oxide enriched gas into the breathing circuit. The device also incorporates a gas monitoring system (with user-set alarms) for measuring the gas concentrations of nitric oxide, nitrogen dioxide (NO2) and oxygen (O2) in the ventilator breathing circuit just prior to inhalation by the patient, via a sampling line.
The system is comprised of three sub-systems: The NO Generator with the NO2 Filter, the Nitric Oxide Backup and Bagging System, and the Gas Sampling and Monitoring System.
Beyond Air, Inc.
90002
In Commercial Distribution
- B882900020 ()
- Nitric oxide delivery unit, system-based
The TriVascular® Ovation Prime® Abdominal Stent Graft System with the Ovation iX Iliac Stent Graft is an endovascular device delivered via a small diameter catheter to treat abdominal aortic aneurysms (AAAs). The stent graft is designed to reline the diseased vasculature, providing an endovascular blood conduit for isolating the aneurysm from the high pressure flow of blood, thereby reducing the risk of rupture. The stent graft is a modular configuration comprised of an aortic body section, iliac limbs, and iliac extensions as required.
The TriVascular Ovation Prime Abdominal Stent Graft System with the Ovation iX Iliac Stent Graft includes, an Aortic Body Stent Graft and delivery catheter, Iliac Limb Stent Grafts and delivery catheters, Iliac Extension Stent Grafts and delivery catheters, as required, a Fill Polymer Kit, and an Autoinjector.
ENDOLOGIX, INC.
Iliac Limb
In Commercial Distribution
- M701TVIL1418160J1 ()
- Catheter Gauge: 13 French
- Length: 160 Millimeter
- Outer Diameter: 18 Millimeter
- Outer Diameter: 14 Micrometer
TV-IL1418160-J
- Abdominal aorta endovascular stent-graft