CENTURION®

Basic Information

• Brand Name: CENTURION®
• Primary DI: 00380657529148
• Version / Model: 8065752914
• Company Name: Alcon Laboratories, Inc.
• Labeler DUNS: 008018525
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-19
• Public Version: 3
• Public Version Date: 2022-01-24
• Public Version Status: Update
• Public Device Record Key: 623fdbb4-80c7-40e4-8a2d-0ea8ee74aadd

Device Description

Centurion Vision System Active Sentry® Handpiece

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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
HQC	Unit, phacofragmentation	Ophthalmic	886.4670	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34900	Phacoemulsification system handpiece	A holder for a dedicated detachable tip that together become a unit that delivers energy (e.g., ultrasonic, piezoelectric), provided from a system generator, to perform phacoemulsification (a procedure for the liquefying and removal of the opaque lens nucleus in cataract surgery). This device will be activated by the surgeon using a foot control and may provide or facilitate the irrigation/suction systems needed for the removal of debris. The handpiece typically designed in the form of a pen or pencil. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380657529148	GS1

Customer Contacts

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