CUSA® Selector®

Basic Information

• Brand Name: CUSA® Selector®
• Primary DI: 10381780040392
• Version / Model: 1523072M1
• 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: b2dfe1da-5fcf-4ec2-9b33-57a49672bb51

Device Description

Only use the CUSA Selector wrench set to tighten and loosen tips and extensions on the handpiece. Always secure the handle of the handpiece in the holder provided. Never assemble or disassemble the handpiece by holding the handle in your hand as damage may occur to the handpiece. The CUSA Selector Wrench Set is intended for use with Standard handpieces.

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: 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: No
• 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
47676	Ultrasonic surgical system torque wrench, single-use	A sterile hand-held instrument designed to manually attach or detach a handpiece tip (blade) from the handpiece of an ultrasonic surgical system. It is typically formed with a socket that is placed over the handpiece tip and rotated by the operator to tighten or loosen, with appropriate torque, the tip to or from the handpiece. The device is made of durable materials and typically includes a mechanism to prevent under- or over-tightening. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780040392	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K021989	000

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Temperature -20°C to 60°C(-4°F to 140°F); Relative Humidity non condensing 25% to 85%.Keep Dry.