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The Alere NMP22 BladderChek Test is an in vitro immunoassay intended for the qualitative detection of the nuclear mitotic apparatus protein (NuMA) in urine of persons with risk factors or symptoms of bladder cancer or with a history of bladder cancer.
Alere Scarborough, Inc.
D1300
Not in Commercial Distribution
- 10811877010774 ()
- Nuclear matrix protein 22 IVD, kit, rapid ICT, clinical
The Alere NMP22 BladderChek Test is an in vitro immunoassay intended for the qualitative detection of the nuclear mitotic apparatus protein (NuMA) in urine of persons with risk factors or symptoms of bladder cancer or with a history of bladder cancer.
Alere Scarborough, Inc.
D1200
Not in Commercial Distribution
- 10811877010569 ()
- Nuclear matrix protein 22 IVD, kit, rapid ICT, clinical
HYMOVIS® is based on an ultra-pure hyaluronan engineered using a proprietary process to increase viscosity, elasticity and residence time without chemical crosslinking. The hyaluronan in HYMOVIS® is derived from bacterial fermentation. HYMOVIS® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy or simple analgesics (e.g., acetaminophen). It is given by intra-articular injection in two injections given at weekly intervals. The product is packaged in a one syringe pack.
FIDIA FARMACEUTICI SPA
89122-0496-01
In Commercial Distribution
- M713891220496010 ()
- Total Volume: 3 Milliliter
89122-0496-01
- Synovial fluid supplementation medium
Paragon HDS® 100 (paflufocon D) rigid gas permeable contact lenses for daily wear and extended wear are available as lathe cut or molded firm contact lenses with spherical front and back surfaces in 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 Paragon HDS ®100 rigid gas permeable contact lens material is a thermoset copolymer derived from fluorosilicone acrylate monomers.
The Paragon HDS ®100 rigid gas permeable tinted lenses offer color enhancement of the eye and a handling aid for locating the lens. These products may be plasma treated.
Paragon Vision Sciences, Inc.
Paragon HDS100
In Commercial Distribution
- B22209 ()
- Orthokeratology contact lens
- Rigid-gas-permeable corrective contact lens, daily-wear
- Rigid-gas-permeable corrective contact lens, extended-wear
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
- M701TVIL1414140J1 ()
- Catheter Gauge: 12 French
- Length: 140 Millimeter
- Outer Diameter: 14 Millimeter
TV-IL1414140-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 Limb
In Commercial Distribution
- M701TVIL141080J1 ()
- Catheter Gauge: 12 French
- Length: 80 Millimeter
- Outer Diameter: 14 Millimeter
- Outer Diameter: 10 Millimeter
TV-IL141080-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
- M701TVEX222245J1 ()
- Catheter Gauge: 14 French
- Length: 45 Millimeter
- Outer Diameter: 22 Millimeter
TV-EX222245-J
- Abdominal aorta endovascular stent-graft
The VISUMAX 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 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 800 or 09511
In Commercial Distribution
- 04049471095111 ()
- Weight: 520 Kilogram
- LxW 1.71m x0.925
- Femtosecond ophthalmic solid-state laser system
Eversense adhesive patch is designed to have an adhesive side that attaches to the back of the smart transmitter and a silicone adhesive side that attaches to the skin. The kit contains five 30-packs of white patches and one 30-pack of clear patches.
SENSEONICS, INCORPORATED
FG-6500-01-300
In Commercial Distribution
- 00817491022882 ()
FG-6500-01-300
- Implantable glucose monitoring system
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