CUSA® Excel

Basic Information

• Brand Name: CUSA® Excel
• Primary DI: 10381780039259
• Version / Model: CUSAEXCEL2
• Catalog Number: CUSAEXCEL2
• Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED
• Labeler DUNS: 989925396
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-29
• Public Version: 6
• Public Version Date: 2023-04-14
• Public Version Status: Update
• Public Device Record Key: 2dfb2e2c-b532-452a-aa6e-2f22d9a7bc22

Device Description

CUSA® Excel + Ultrasonic Tissue Ablation System

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LBK	Device, neurosurgical fragmentation and aspiration	Unknown		U
LFL	Instrument, ultrasonic surgical	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
44778	Soft-tissue ultrasonic surgical system	An assembly of devices that converts high frequency current into ultrasonic oscillation to mechanically fragment soft-tissue cells upon contact with a vibrating tip for cutting and/or coagulating tissue during surgery, possibly in combination with irrigation and aspiration. Ongoing vibration may create heat in cells (diathermy) to increase the cutting/coagulating capacity. It typically includes an energy-producing generator with monitoring functions, a handpiece(s) with tip(s) to convert and apply the energy, connecting cables, a foot-switch as an option to regulate the energy, and possibly an integrated irrigation/suction system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M273CUSAEXCEL21	HIBCC
Primary	10381780039259	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Console 132cm (52in) height x 55.88cm (22in) width x 71.12cm (28in) depth, 93kg (200lbs) weight; Footswitch 5.08cm (2in) height x 30.48cm (12in) width; Cable 4.575m (15ft) length

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Temperature: -34°C (-29°F) to +65°C (149°F). Relative Humidity, non-condensing: +25% to +85%.