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The modular DIPLOMAT® pedicle screw system is a rod-screw system that firmly connects two or more screws via the screw head and a rod using a force-fit or form-fit connection. Additional fixation elements, such as cross bars, hooks, connectors and washers, can also be used. The DIPLOMAT® pedicle screw system is applied temporarily to provide internal posterior stabilization until bone fusion in the lumbar or thoracic spine has taken place. The surgeon makes the final decision as to the indwelling time of the implant in the patient‘s body and the time when the implant is to be explanted. The pedicle screw system is implanted from a posterior approach. The implant is screwed into the vertebral body via the pedicle and it can be applied in a single segment or multiple segments. Implantation is facilitated by use of the specially developed accessories for inserting and positioning the implants. Only these accessories ensure safe use. Our product information provides further system-related information on the surgical method. If there are any preoperative uncertainties relating to the implant, information must be obtained from SIGNUS. Instruments specially developed by SIGNUS to ensure safe application are available for use with the implant system.
SIGNUS Medizintechnik GmbH
Round rod, straight
In Commercial Distribution
- 04047844013793 ()
- Ø5,5x500mm
LSZ3000
- Bone-screw internal spinal fixation system rod
MINI LPV II SHUNT KIT, MED.
The Integra LPV II Valve Shunt Kits are designed to deliver CSF from the ventricles of the brain to the peritoneal cavity. The kit contains a LPV II valve, mini, a Pudenz Ventricular Catheter and an integral, open-ended kink resistant catheter attached to the outlet of the valve. The kit is available in a medium pressure range. All valves and catheters contain barium sulfate for x-ray detectability.
Integra Lifesciences Corporation
NL8509851
Not in Commercial Distribution
- 10381780072492 ()
- M269NL85098511 ()
- Valve Length: 30.3mm, Valve Width: 13.0mm, Profile Height: 6mm
NL8509851
- Ventriculoperitoneal shunt
STANDARD LPV II SHUNT KIT, MED.
The Integra LPV II Valve Shunt Kits are designed to deliver CSF from the ventricles of the brain to the peritoneal cavity. The kit contains a LPV II valve, standard, a Pudenz Ventricular Catheter and an integral, open-ended kink resistant catheter attached to the outlet of the valve. The kit is available in a medium pressure range. All valves and catheters contain barium sulfate for x-ray detectability.
Integra Lifesciences Corporation
NL8509850
In Commercial Distribution
- 10381780072485 ()
- M269NL85098501 ()
- Valve Length: 36.7mm, Valve Width: 16.7mm, Profile Height: 7.8mm
NL8509850
- Ventriculoperitoneal shunt
The Model 2740C Programmer Cable is responsible for transferring device data from the generator through the skin via short-range inductive radiofrequency (RF) telemetry. The programmer cable is powered by a wall outlet connection and wirelessly transfers data (via Bluetooth Low Energy) to the tablet.
Inspire Medical Systems, Inc.
900-018-001
In Commercial Distribution
- 00855728005994 ()
2740C
- Implantable sleep apnoea treatment system, respiration-sensing
The Padlock Clip EFTR Kit includes the EFTR Device, Raptor grasping device, and TouchSoft Coagulator Probe. It is designed for use in a flexible endoscope intended for the diagnostic tissue acquisition and full-thickness resection through the removal of lesions in the colon and rectum.
US Endoscopy
00713229
In Commercial Distribution
- 00724995226732 ()
- Length: 230 Centimeter
- Outer Diameter: 2.4 Millimeter
00713229
- Flexible endoscopic tissue manipulation forceps, single-use
- Gastrointestinal endoscopic clip, long-term, non-bioabsorbable
- Inert gas-enhanced endoscopic electrosurgical electrode, reusable
The Model 2740S&C Programmer Cable is responsible for transferring device data from the generator through the skin via short-range inductive radiofrequency (RF) telemetry. The programmer cable is powered by a wall outlet connection and wirelessly transfers data (via Bluetooth Low Energy) to the tablet.
Inspire Medical Systems, Inc.
900-026-001
In Commercial Distribution
- 00810098650311 ()
2740S&C
- Implantable sleep apnoea treatment system, respiration-sensing
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
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-23
In Commercial Distribution
- 00851788001662 ()
- Outer Diameter: 23 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-21
In Commercial Distribution
- 00851788001655 ()
- Outer Diameter: 21 Millimeter
- Aortic bi-leaflet mechanical heart valve prosthesis