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10 mm Flat Perforated, 3/4 size Kit with 100 cc Evacuator
TYPENEX MEDICAL LLC
WD0402PK1
In Commercial Distribution
- 00851878008854 ()
- 00851878008847 ()
- Closed-wound drainage kit
10 mm Flat Perforated, Full with 100 cc Evacuator
TYPENEX MEDICAL LLC
WD0402K1
In Commercial Distribution
- 00851878008816 ()
- 00851878008809 ()
- Closed-wound drainage kit
7 mm Flat Perforated, 3/4 size Kit with 100 cc Evacuator
TYPENEX MEDICAL LLC
WD0401PK1
In Commercial Distribution
- 00851878008779 ()
- 00851878008762 ()
- Closed-wound drainage kit
7 mm Flat Perforated, Full Kit with 100 cc Evacuator
TYPENEX MEDICAL LLC
WD0401K1
In Commercial Distribution
- 00851878008571 ()
- 00851878008564 ()
- Closed-wound drainage kit
Drain Glider 10 Pack
TYPENEX MEDICAL LLC
WD0808QX
In Commercial Distribution
- 00851878008298 ()
- 00810050855174 ()
- Closed-wound drainage kit
Drain Glider Individual Packaged, 100 Each
TYPENEX MEDICAL LLC
WD0809QC
In Commercial Distribution
- 00851878008281 ()
- 00810050855181 ()
- Closed-wound drainage kit
Insulated Dilator Set, 7, 12, & 15 MM, Sterile
TEDAN SURGICAL INNOVATIONS, L.L.C.
ML-0444S
In Commercial Distribution
- 00851797006436 ()
- Width: 14.9 Millimeter
- Width: 12 Millimeter
- Width: 7 Millimeter
- Lumbar interspinous decompression instrument set, single-use
XL INSULATED DILATORS
TEDAN SURGICAL INNOVATIONS, L.L.C.
ML-0440S
Not in Commercial Distribution
- 00851797006191 ()
- Width: 8 Millimeter
- Width: 13 Millimeter
- Lumbar interspinous decompression instrument set, single-use
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.
ONXANE-27/29
In Commercial Distribution
- 00851788001686 ()
- Outer Diameter: 29 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.
ONXANE-25
In Commercial Distribution
- 00851788001679 ()
- Outer Diameter: 25 Millimeter
- Aortic bi-leaflet mechanical heart valve prosthesis