Address:IDA BUSINESS and TECHNOLOGY PARK,SRAGH TULLAMORE Offaly,IE
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 : The CUSA® Extended MicroTip™ Plus is intended for surgical procedures where frag The CUSA® Extended MicroTip™ Plus is intended for surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery and Thoracoscopic Surgery.
Device Class : U
Duns Number: 989925396
Premarket Exempt : No
Prescription Use : Yes
Device Description : The CUSA® SaberTip™ is intended for surgicalprocedures where fragmentation, emul The CUSA® SaberTip™ is intended for surgicalprocedures where fragmentation, emulsificationand aspiration of hard (e.g.: bone) tissue is desirable,including Neurosurgery, Plastic and ReconstructiveSurgery, General Surgery, Orthopedic Surgery,Gynecological Surgery, Thoracic Surgery, LaparoscopicSurgery and Thoracoscopic Surgery. The CUSA® SaberTip™ is intended to be used for bone. Soft tissue should be avoided during use. Do not use excessive force with the CUSA® SaberTip™.
Device Class : U
Duns Number: 989925396
Premarket Exempt : No
Prescription Use : Yes
Device Description : The CUSA® ShearTip™ is intended for surgical procedures where fragmentation, emu The CUSA® ShearTip™ is intended for surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery and Thoracoscopic Surgery. Please see warning text in the Instructions For Use.
Device Class : U
Duns Number: 989925396
Premarket Exempt : No
Prescription Use : Yes
Device Description : Excel Tip Torquing Set EACH1: The CUSA Excel Tip Torquing Set consists of a han Excel Tip Torquing Set EACH1: The CUSA Excel Tip Torquing Set consists of a handpiece mounting base, a double headed torque limiting wrench and a reusable storage container. This device provides the means for the user to attach and remove all tip configurations from the CUSA Excel 23 kHz Handpieces as well as the 36 kHz Excel Handpiece.
Device Class : U
Duns Number: 989925396
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Sterile Torque Wrench is used to correctly assemble and disassemble tips on The Sterile Torque Wrench is used to correctly assemble and disassemble tips on the CUSA Excel 23 kHz straight or angled handpieces.
Device Class :
Duns Number: 989925396
Premarket Exempt : No
Prescription Use : Yes
Device Description : The Sterile Torque Wrench is used to correctly assemble and disassemble tips on The Sterile Torque Wrench is used to correctly assemble and disassemble tips on the CUSA Excel 36 kHz straight handpiece.
Device Class :
Duns Number: 989925396
Premarket Exempt : No
Prescription Use : Yes
Device Description : The CUSA Electrosurgical Module provides Desiccate Coagulation waveform electros The CUSA Electrosurgical Module provides Desiccate Coagulation waveform electrosurgical capability to CUSA® Excel handpieces. The CEM nosecone is intended for use with the CUSA® Excel/ CUSA® Excel+ UltrasonicSurgical Aspirator System, CUSA handpiece and the Covidien Force FX® Electrosurgical Generator. The CUSA handpiece with the CEM nosecone works in conjunction with the Force FX Generator in surgical procedureswhere combined ultrasonic dissection/electrosurgical coagulation is desired (simultaneously or independently).
Device Class :
Duns Number: 989925396
Premarket Exempt : No
Prescription Use : Yes
Device Description : The CUSA Electrosurgical Module provides Desiccate Coagulation waveform electros The CUSA Electrosurgical Module provides Desiccate Coagulation waveform electrosurgical capability to CUSA® Excel handpieces. The CEM nosecone is intended for use with the CUSA® Excel/ CUSA® Excel+ UltrasonicSurgical Aspirator System, CUSA handpiece and the Covidien Force FX® Electrosurgical Generator. The CUSA handpiece with the CEM nosecone works in conjunction with the Force FX Generator in surgical procedureswhere combined ultrasonic dissection/electrosurgical coagulation is desired (simultaneously or independently).
Device Class :
Duns Number: 989925396
Premarket Exempt : No
Prescription Use : Yes