CUSA® NXT

Basic Information

• Brand Name: CUSA® NXT
• Primary DI: 10381780039488
• Version / Model: NXT3220
• 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: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: c6036488-72c9-4229-9b93-ab84d01c89fe

Device Description

The CUSA NXT Bone Tips are accessories to the CUSA NXT Ultrasonic Surgical Aspirator System that is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) 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 Characteristics

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

Sterilization

• Is Sterile: Yes
• 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
44755	Soft-tissue ultrasonic surgical system handpiece tip, single-use	A sterile removable endpiece intended to be attached to an ultrasonic surgical system handpiece, and makes contact with a patient while oscillating (vibrating) at high frequency in order to fragment soft-tissue cells for cutting and/or coagulating tissue during surgery. The device comes in a variety of forms (e.g., blade, cylinder, pincers) and sizes, and is typically made of metal; it is not intended to be held directly (i.e., does not include a holder). This device is utilized in a variety of surgical disciplines (e.g., neurosurgery, general surgery, surgical oncology, gynaecology, and urology). This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30381780039482	GS1	BOX	5	In Commercial Distribution
Primary	10381780039488	GS1
Secondary	M269NXT322011	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K113570	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Temperature -20°C to 60°C; Relative Humidity 25% to 85%; Keep Dry.