CUSA® Selector®

Basic Information

• Brand Name: CUSA® Selector®
• Primary DI: 10381780040408
• Version / Model: 1523072M2
• 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: d41c97a1-ca65-4e82-ab56-8e7d0a7aae3e

Device Description

Selector Wrench Set : The Selector Wrench Set consists of a stainless steel holder and spanner, connected by a chain. The Wrench set is used to assemble the handpiece and tip, and to change tips in the sterile field. The Wrench Set is also used to disassemble the handpiece for cleaning and sterilization. The cut-outs in the holder are sized according to its use with specific handpieces.The wrench sets are required to ensure the tips are attached to the hand pieces correctly.

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: 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
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	10381780040408	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 (-4°F) to +60°C (+140°F). Humidity: 25% to 85%. Keep dry.