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The On-X® Prosthetic Heart Valve is a bileaflet mechanical heart valve, which consists of an orifice housing and two leaflets. The orifice inflow area has a flared inlet designed to reduce flow turbulence, and the outflow rim consists of leaflet guards designed to protect the leaflets while in the closed position. The leaflets rotate around tabs located within the inner circumference of the orifice ring. In the closed position, each leaflet forms a nominal angle of 40º relative to the plane of the orifice. In the open position, the plane of each leaflet forms a nominal angle of 90deg relative to the plane of the orifice. The leaflets have a travel arc of 50deg to the closed position.
The orifice, or housing, is composed of a graphite substrate coated with On-X® Carbon, a pure unalloyed form of pyrolytic carbon. The leaflets consist of On-X® Carbon deposited on a graphite substrate, which is impregnated with 10 weight% tungsten to provide radiopacity.
The sewing cuff is constructed of polytetrafluoroethylene (PTFE) fabric mounted on the orifice using titanium retaining rings and 5-0 suture material. This form of sewing cuff attachment to the orifice allows for rotation of the sewing cuff in situ during implantation. Orientation reference marks are provided on the sewing cuff for valve orientation.
The On-X® Prosthetic Heart Valve is available in 3 aortic and 2 mitral sewing cuff configurations. Aortic configurations are available in sizes 19, 21, 23, 25, and 27/29 mm. The standard mitral cuff is available in sizes 23, 25, 27/29 and 31/33, while the Conform-X® mitral cuff is available in size 25/33 only.
Further detail for the On-X prosthetic heart valve is described in the Summary of Safety and Effectiveness documents for the On-X heart valves: http://www.accessdata.fda.gov/cdrh_docs/pdf/P000037b.pdf (aortic), and http://www.accessdata.fda.gov/cdrh_docs/pdf/P000037S001b.pdf (mitral).
ON-X LIFE TECHNOLOGIES, INC.
ONXA-21
In Commercial Distribution
- 00851788001228 ()
- Outer Diameter: 21 Millimeter
- Aortic bi-leaflet mechanical heart valve prosthesis
The On-X® Prosthetic Heart Valve is a bileaflet mechanical heart valve, which consists of an orifice housing and two leaflets. The orifice inflow area has a flared inlet designed to reduce flow turbulence, and the outflow rim consists of leaflet guards designed to protect the leaflets while in the closed position. The leaflets rotate around tabs located within the inner circumference of the orifice ring. In the closed position, each leaflet forms a nominal angle of 40º relative to the plane of the orifice. In the open position, the plane of each leaflet forms a nominal angle of 90deg relative to the plane of the orifice. The leaflets have a travel arc of 50deg to the closed position.
The orifice, or housing, is composed of a graphite substrate coated with On-X® Carbon, a pure unalloyed form of pyrolytic carbon. The leaflets consist of On-X® Carbon deposited on a graphite substrate, which is impregnated with 10 weight% tungsten to provide radiopacity.
The sewing cuff is constructed of polytetrafluoroethylene (PTFE) fabric mounted on the orifice using titanium retaining rings and 5-0 suture material. This form of sewing cuff attachment to the orifice allows for rotation of the sewing cuff in situ during implantation. Orientation reference marks are provided on the sewing cuff for valve orientation.
The On-X® Prosthetic Heart Valve is available in 3 aortic and 2 mitral sewing cuff configurations. Aortic configurations are available in sizes 19, 21, 23, 25, and 27/29 mm. The standard mitral cuff is available in sizes 23, 25, 27/29 and 31/33, while the Conform-X® mitral cuff is available in size 25/33 only.
Further detail for the On-X prosthetic heart valve is described in the Summary of Safety and Effectiveness documents for the On-X heart valves: http://www.accessdata.fda.gov/cdrh_docs/pdf/P000037b.pdf (aortic), and http://www.accessdata.fda.gov/cdrh_docs/pdf/P000037S001b.pdf (mitral).
ON-X LIFE TECHNOLOGIES, INC.
ONXA-19
In Commercial Distribution
- 00851788001211 ()
- Outer Diameter: 19 Millimeter
- Aortic bi-leaflet mechanical heart valve prosthesis
INTEGRA Dermal Regeneration Template 8in. x 10in. (20cm x 25cm) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and a glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. The epidermal substitute layer is made of a thin polysiloxane (silicone) layer to control moisture loss from the wound.
Integra Lifesciences Corporation
38105
In Commercial Distribution
- M269381051 ()
- 10381780000617 ()
- 00381780000610 ()
- 8 in x 10 in
38105
- Collagen wound matrix dressing
INTEGRA Dermal Regeneration Template 4in. x 10in. (10cm x 25cm) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and a glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. The epidermal substitute layer is made of a thin polysiloxane (silicone) layer to control moisture loss from the wound.
Integra Lifesciences Corporation
34105
In Commercial Distribution
- M269341051 ()
- 10381780000594 ()
- 00381780000597 ()
- 4 in x 10 in
34105
- Collagen wound matrix dressing
INTEGRA Dermal Regeneration Template 4in. x 5in. (10cm x 12.5cm) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and a glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. The epidermal substitute layer is made of a thin polysiloxane (silicone) layer to control moisture loss from the wound.
Integra Lifesciences Corporation
34055
In Commercial Distribution
- M269340551 ()
- 10381780000570 ()
- 00381780000573 ()
- 4 in x 5 in
34055
- Collagen wound matrix dressing
INTEGRA Dermal Regeneration Template 2in. x 2in. (5cm x 5cm) is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and a glycosaminoglycan (chondroitin-6-sulfate) that is manufactured with a controlled porosity and defined degradation rate. The epidermal substitute layer is made of a thin polysiloxane (silicone) layer to control moisture loss from the wound.
Integra Lifesciences Corporation
32025
In Commercial Distribution
- M269320251 ()
- 10381780000556 ()
- 00381780000559 ()
- 2 in x 2 in
32025
- Collagen wound matrix dressing
SILIKON™ 1000 (purified polydimethylsiloxane) is highly purified long chain polydimethylsiloxane trimethylsiloxy terminated silicone oil. It is sterile,
non-pyrogenic, clear, colorless and has a viscosity of 1000 cs. for use as a post-operative retinal tamponade during vitreoretinal surgery. SILIKON™ 1000
is composed of silicon, oxygen, carbon and hydrogen atoms. SILIKON™ 1000 is immiscible with aqueous components and is relatively inert material with
little biological toxicity potential.
Alcon Laboratories, Inc.
8065601187
In Commercial Distribution
- 00380656011873 ()
- Total Volume: 8.5 Milliliter
- Aqueous/vitreous humour replacement medium kit
The Cordella Pulmonary Artery Sensor System is designed for on-demand measurement of pulmonary artery pressure from the patient’s home. Cordella Data Analysis Platform (CDAP) is a component of the Cordella Pulmonary Artery Sensor System.
The Cordella Data Analysis Platform (CDAP) is a secure, cloud-based, standalone application that collects and stores raw Reader data
and processes it according to pre-defined algorithms to convert it into final-form pulmonary artery pressure data.
Endotronix, Inc.
100543-00
In Commercial Distribution
- 00850008997051 ()
- Implantable pulmonary artery pressure monitoring system
Gel-One is a cross-linked hyaluronate hydrogel that is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to non-pharmacologic therapy, non-steroidal anti-inflammatory drugs (NSAIDs) or analgesics (e.g., acetaminophen). Gel-One is physician-administered, and is injected directly into the cavity of the knee joint. It is delivered via a single-use, pre-filled disposable glass syringe containing 3 mL of Gel-One.
SEIKAGAKU CORPORATION
00-1111-001-00
In Commercial Distribution
- 04987541300911 ()
00-1111-001-00
- Synovial fluid supplementation medium
The TherOx DownStream System, is indicated for the preparation and delivery of SuperSaturated Oxygen Therapy (SSO2 Therapy) to targeted ischemic regions perfused
by the patient’s left anterior descending coronary artery immediately following revascularization by means of percutaneous coronary intervention (PCI) with stenting
that has been completed within 6 hours after the onset of anterior acute myocardial infarction (AMI) symptoms caused by a left anterior descending artery infarct lesion.
THEROX, INC.
SSO2 - 5.0
In Commercial Distribution
- 20862478000463 ()
- 00862478000469 ()
- 10862478000466 ()
- 5F
- Supersaturated oxygen therapy system catheter