CUSA® Clarity

Basic Information

• Brand Name: CUSA® Clarity
• Primary DI: 10381780536376
• Version / Model: C7523XEA
• Catalog Number: C7523XEA
• Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED
• Labeler DUNS: 989925396
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-14
• Public Version: 1
• Public Version Date: 2023-07-24
• Public Version Status: New
• Public Device Record Key: 26db582c-ef3f-45fd-99d3-2705e3063c1d

Device Description

CUSA Clarity 23kHz Expanded CEM Nosecone (Single Pack)

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: 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: 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
LBK	Neurosurgical ultrasonic instruments	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
47547	Ultrasonic surgical system adaptor, single-use	A small, sterile, connecting device designed to fit between the component devices of an ultrasonic surgical system (i.e., the handpiece tip, handpiece, and generator) to enable them to join each other. It may include controls (e.g., buttons) that allow the operator to activate different power level settings for the system during surgery. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10381780536376	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K230427	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -18 – 60 Degrees Celsius
• Type: Handling Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry, Do not use if package is damaged
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 500 – 1060 millibar
• Type: Handling Environment Humidity
• Temperature Range: 30 – 85 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 700 – 1060 millibar
• Type: Storage Environment Humidity
• Temperature Range: 15 – 85 Percent (%) Relative Humidity