CUSA® Selector®

Basic Information

• Brand Name: CUSA® Selector®
• Primary DI: 10381780040682
• Version / Model: 1523032
• Catalog Number: 1523032
• Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED
• Labeler DUNS: 989925396
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• 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: 6392adcb-9495-4a8e-b24a-df39ba9e2ae0

Device Description

CUSA® Selector® 24kHz Laparascopic Flue (Pack of 10)

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: No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LFL	Instrument, ultrasonic surgical	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
45184	Ultrasonic surgical system flue	A sterile device used to encompass the distal end of a dedicated ultrasonic surgical system handpiece and tip to provide a pathway for the delivery of irrigation fluid. The device helps to concentrate the fluid at the tip of the handpiece, remove some of the heat generated during surgery, eliminate misting that can impair visibility of the surgical site, and reduce the amount of irrigant needed. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M27315230321	HIBCC
Primary	10381780040682	GS1
Unit of Use	00381780040685	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K021989	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			24kHz Ultrasonic Frequency

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Temperature: -20°C (-4°F) to +60°C (+140°F). Relative Humidity, non-condensing: +25% to +85%. Avoid excessive heat and humidity. Keep dry.