PUREPOINT

Basic Information

• Brand Name: PUREPOINT
• Primary DI: 00380657515028
• Version / Model: 8065751502
• Company Name: Alcon Laboratories, Inc.
• Labeler DUNS: 008018525
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-31
• Public Version: 3
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: 14b419ab-a1e8-4e12-bd69-06d0cf970554

Device Description

PUREPOINT Laser 532nm Optical Laser Filter

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: No
• MRI Safety: Labeling does not contain MRI Safety Information
• 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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HQF	Laser, ophthalmic	Ophthalmic	886.4390	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36308	Operator eye protection laser filter	An eyepiece intended to be fitted to a device used during a laser procedure (e.g., surgical laser system, endoscope, surgical microscope) to protect the operator's eyes from laser energy. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00380657515028	GS1

Customer Contacts

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