CUSA® NXT

Basic Information

• Brand Name: CUSA® NXT
• Primary DI: 10381780039280
• Version / Model: CUSANXT
• Catalog Number: CUSANXT
• 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: 5
• Public Version Date: 2023-04-14
• Public Version Status: Update
• Public Device Record Key: 8fe9d9de-bbc4-4c9c-8391-e8eafd079f7b

Device Description

CUSA® NXT Console

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
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	M273CUSANXT1	HIBCC
Primary	10381780039280	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K081459	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Console 31.08cm(12.5in)height, 45.7cm(18in)width, 58.9cm(23.2in)depth, 20.9kg (46lbs)weight; Footswitch 6cm(2.4in)height, 19.5cm (7.7in)width, 22cm (8.7in)depth, 5.81m(19ft)length, 2kg(4.4lbs)weight

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Temperature: -20°C (-4°F) to +60°C (+140°F). Humidity: +25% to +85%. Atmospheric Pressure: +500hPa to +1100hPa. Keep dry.