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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 Extension
In Commercial Distribution
- M701TVEX161645J1 ()
- Catheter Gauge: 13 French
- Length: 45 Millimeter
- Outer Diameter: 16 Millimeter
TV-EX161645-J
- Abdominal aorta endovascular stent-graft
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 Extension
In Commercial Distribution
- M701TVEX101045J1 ()
- Catheter Gauge: 12 French
- Length: 45 Millimeter
- Outer Diameter: 10 Millimeter
TV-EX101045-J
- Abdominal aorta endovascular stent-graft
The Praxis™ Extended RAS Panel assay is designed specifically for the detection of 56 mutations from exons 2, 3, and 4 of the KRAS and NRAS genes using the Illumina MiSeqDx Instrument. The assay has been configured for 2 runs with a maximum of 10 samples plus 2 controls per run.
Illumina provides the following reagents for the Illumina Praxis Extended RAS Panel: 20012195, Praxis Extended RAS Panel – 1/6; 20012196, Praxis Extended RAS Panel – 1A; 20012197, Praxis Extended RAS Panel – 1B; 20012198, Praxis Extended RAS Panel – 2/6; 20012199, Praxis Extended RAS Panel – 3/6; 20012200, Praxis Extended RAS Panel – 3A; 20012201, Praxis Extended RAS Panel – 3B; 20012202, Praxis Extended RAS Panel – 4/6; 20012203, Praxis Extended RAS Panel – 5/6; and 20012204, Praxis Extended RAS Panel – 6/6.
ILLUMINA, INC.
20012431
Not in Commercial Distribution
- 00816270020088 ()
20012431
- Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
The Access Hybritech free PSA assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free prostate specific antigen (free PSA) in human serum using the Access Immunoassay Systems. Access Hybritech free PSA is intended to be used with Hybritech (total) PSA to calculate the ratio of free PSA to total PSA expressed as a percentage (percent free PSA). Percent free PSA as measured by the Hybritech assays is indicated for use as an aid in distinguishing prostate cancer from benign prostatic conditions, when used in conjunction with Hybritech (total) PSA for prostate cancer detection in men aged 50 years and older with total PSA between 4 and 10 ng/mL with digital rectal examination findings that are not suspicious for cancer. Prostatic biopsy is required for diagnosis of cancer.
Beckman Coulter, Inc.
C22846
In Commercial Distribution
- 15099590701680 ()
C22846
- Free (unbound) prostate specific antigen (fPSA) IVD, kit, chemiluminescent immunoassay
ACCY KIT 3550-06 TUNNELING TOOL US FWU
MEDTRONIC, INC.
3550-06
Not in Commercial Distribution
- 00643169887459 ()
- Subcutaneous tunneller, single-use
ACCESSORY 3550-06 TUNNELING TOOLS
MEDTRONIC, INC.
3550-06
Not in Commercial Distribution
- 10681490078013 ()
- Subcutaneous tunneller, single-use
The TruSight Oncology Comprehensive assay is an enrichment-based targeted next generation sequencing (NGS) in-vitro diagnostic test comprised of library preparation and enrichment reagents to enable DNA and/or RNA sequencing from Formalin-Fixed, Paraffin-Embedded (FFPE) tissue from solid tumors encompassing multiple cancer types.
ILLUMINA, INC.
20032573
In Commercial Distribution
- 00816270020217 ()
- Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
Radiesse (+) Lidocaine Injectable Implant is a volumizing filler with lidocaine indicated for subdermal implamantation for the correction of moderate to severe folds, such as nasolabial folds. Radiesse (+) Kit contains (1) 0.8cc Injectable Implant and (2) 27 gauge thin walled x 0.75" needles.
MERZ NORTH AMERICA, INC.
8067M0K1
In Commercial Distribution
- M2138067M0K15 ()
- Total Volume: 0.8 Milliliter
- Dermal tissue reconstructive material, microbe-derived, anaesthetic
Tiered-therapy cardioverter/defibrillator VVEV VVIR
ST. JUDE MEDICAL, INC.
CD1411-36Q
In Commercial Distribution
- 05414734507738 ()
- Total Volume: 30.2 Milliliter
CD1411-36Q
- Single-chamber implantable defibrillator
DR Implantable Cardioverter Defibrillator VVED DDDR
ST. JUDE MEDICAL, INC.
CD2411-36Q
In Commercial Distribution
- 05414734507615 ()
- Total Volume: 31.3 Milliliter
CD2411-36Q
- Dual-chamber implantable defibrillator