CUSA® Clarity

Basic Information

• Brand Name: CUSA® Clarity
• Primary DI: 10381780466246
• Version / Model: C7601
• Catalog Number: C7601
• Company Name: INTEGRA LIFESCIENCES (IRELAND) LIMITED
• Labeler DUNS: 989925396
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-16
• Public Version: 4
• Public Version Date: 2023-04-14
• Public Version Status: Update
• Public Device Record Key: 9a12475f-d4c0-4074-b33b-c6084253b9dc

Device Description

CUSA® Clarity Torque Wrench

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
LFL	Instrument, ultrasonic surgical	Unknown		U
LBK	Device, neurosurgical fragmentation and aspiration	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
Package	30381780466240	GS1	Box	5	In Commercial Distribution
Primary	10381780466246	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep Dry, Do not use if package is damaged
• Type: Handling Environment Temperature
• Temperature Range: 10 – 35 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 500 – 1060 millibar
• 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