Address:IDA BUSINESS and TECHNOLOGY PARK,SRAGH TULLAMORE Offaly,IE
Device Description : The Integra PAC1 cable is intended for use with Camino CAM01 and MPM monitors an The Integra PAC1 cable is intended for use with Camino CAM01 and MPM monitors and Camino Flex catheter products to support the direct and continuous measurement of intracranial pressure (ICP) and intracranial temperature (ICT) when connected to the MPM or Camino CAM01 intracranial pressure ICP monitor. The device is a reusable product.
Device Class : 2
Duns Number: 989925396
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Tips are machined hollow tubes with fittings at the distal end which connect The Tips are machined hollow tubes with fittings at the distal end which connect to the handpiece. They are manufactured from titanium alloy. The Tips deliver the mechanical motion to ablate the tissues then aspirate the waste fluid and suspended tissue pieces. The Flues are hollow cones. The Flues are intended to direct the saline irrigation fluid to the site of operation. They are manufactured from clear plastic.
Device Class :
Duns Number: 989925396
Premarket Exempt : No
Prescription Use : Yes
Device Description : Excel Contamination Guard BOX2: The Contamination Guard is compatible with the C Excel Contamination Guard BOX2: The Contamination Guard is compatible with the CUSA® Excel family of Ultrasonic Surgical Aspirator systems. The CUSA Excel Contamination Guard is a mechanical shut off valve that prevents liquids and aspirated tissue from reaching the vacuum pump. The Contamination Guard packing contains two (2) individual, non-sterile, Contamination Guards. The Contamination Guard is sold non-sterile. The contamination guard will be changed at maximum every six months or sooner if necessary.
Device Class :
Duns Number: 989925396
Premarket Exempt : No
Prescription Use : Yes
Device Description : Excel 23kHz Handpiece ELT Maintenance Kit BOX36: The maintenance kit maintains t Excel 23kHz Handpiece ELT Maintenance Kit BOX36: The maintenance kit maintains the reliability of the handpiece connecting body and tip. The life of the handpiece can be prolonged by avoiding direct contact with metal instruments or bone and by making proper use of a maintenance kit whenever you observe pitting on the connecting body or tip .The maintenance kit can be used with all 23 kHz CUSA EXcel handpieces and extended life tips.
Device Class :
Duns Number: 989925396
Premarket Exempt : No
Prescription Use : Yes
Device Description : The manifold tubing connects the handpiece to the IV fluid, and connects the han The manifold tubing connects the handpiece to the IV fluid, and connects the handpiece to the suction canister on the CUSA® Excel. The manifold tubing supplies IV fluid to the handpiece for use at the surgical site, and it removes fragmented tissue and IV fluid away from the surgical site.
Device Class :
Duns Number: 989925396
Premarket Exempt : No
Prescription Use : Yes
Device Description : The manifold tubing connects the handpiece to the IV fluid, and connects the han The manifold tubing connects the handpiece to the IV fluid, and connects the handpiece to the suction canister on the CUSA® Excel. The manifold tubing supplies IV fluid to the handpiece for use at the surgical site, and it removes fragmented tissue and IV fluid away from the surgical site.
Device Class :
Duns Number: 989925396
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Nosecone attaches to the handpiece and covers the connecting body of the han The Nosecone attaches to the handpiece and covers the connecting body of the handpiece and the tip. It is designed to hold the flue in place and anchor the suction tube. Reusable nosecones are non-sterile devices.
Device Class : U
Duns Number: 989925396
Premarket Exempt : No
Prescription Use : Yes
Device Description : Sterile Tips are intended for use with the CUSA® Excel/ CUSA® Excel+ Ultrasonic Sterile Tips are intended for use with the CUSA® Excel/ CUSA® Excel+ Ultrasonic Surgical Aspirator System, CUSA® Handpiece and accessories. This System is indicated for use in these surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue is desirable: Neurosurgery/Gastrointestinal and affiliated organ surgery/Urological surgery/Plastic and reconstructive surgery/General surgery/Orthopedic surgery/Gynecological surgery/Thoracic surgery/Laparoscopic surgery/Thoracoscopic surgery.
Device Class :
Duns Number: 989925396
Premarket Exempt : No
Prescription Use : Yes
Device Description : Sterile Tips are intended for use with the CUSA® Excel/ CUSA® Excel+ Ultrasonic Sterile Tips are intended for use with the CUSA® Excel/ CUSA® Excel+ Ultrasonic Surgical Aspirator System, CUSA® Handpiece and accessories. This System is indicated for use in these surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue is desirable: Neurosurgery/Gastrointestinal and affiliated organ surgery/Urological surgery/Plastic and reconstructive surgery/General surgery/Orthopedic surgery/Gynecological surgery/Thoracic surgery/Laparoscopic surgery/Thoracoscopic surgery.
Device Class :
Duns Number: 989925396
Premarket Exempt : No
Prescription Use : Yes
Device Description : Sterile Tips are intended for use with the CUSA® Excel/ CUSA® Excel+ Ultrasonic Sterile Tips are intended for use with the CUSA® Excel/ CUSA® Excel+ Ultrasonic Surgical Aspirator System, CUSA® Handpiece and accessories. This System is indicated for use in these surgical procedures where fragmentation, emulsification and aspiration of soft and hard tissue is desirable: Neurosurgery/Gastrointestinal and affiliated organ surgery/Urological surgery/Plastic and reconstructive surgery/General surgery/Orthopedic surgery/Gynecological surgery/Thoracic surgery/Laparoscopic surgery/Thoracoscopic surgery.
Device Class :
Duns Number: 989925396
Premarket Exempt : No
Prescription Use : Yes