CUSA® Clarity

Basic Information

• Brand Name: CUSA® Clarity
• Primary DI: 10381780466215
• Version / Model: C7523
• Catalog Number: C7523
• Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED
• Labeler DUNS: 989925396
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-05-07
• Public Version: 3
• Public Version Date: 2023-04-14
• Public Version Status: Update
• Public Device Record Key: b21912d2-e20b-4fdf-9062-8246584d4af9

Device Description

CUSA® Clarity Nosecone

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: 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
LBK	Device, neurosurgical fragmentation and aspiration	Unknown		U
LFL	Instrument, ultrasonic surgical	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
Package	30381780466219	GS1	Box	5	In Commercial Distribution
Primary	10381780466215	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K190180	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			23kHz Ultrasonic Frequency

Storage Conditions

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