CUSA® Clarity

Basic Information

• Brand Name: CUSA® Clarity
• Primary DI: 10381780126324
• Version / Model: C7005
• Catalog Number: C7005
• Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED
• Labeler DUNS: 989925396
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2016-11-23
• Public Version: 8
• Public Version Date: 2023-04-14
• Public Version Status: Update
• Public Device Record Key: 9e802949-cf3a-494c-bc41-bfa35170cd33

Device Description

CUSA® Clarity Contamination Guard

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: MR Unsafe
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LFL	Instrument, ultrasonic surgical	Unknown		U
LBK	Device, neurosurgical fragmentation and aspiration	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
Primary	10381780126324	GS1
Unit of Use	00381780126327	GS1

Customer Contacts

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

Storage Conditions

• Type: Handling Environment Humidity
• Temperature Range: 30 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 15 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -18 – 60 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 500 – 1060 millibar
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry