Millennium

Basic Information

• Brand Name: Millennium
• Primary DI: 00190776360238
• Version / Model: 85-72053810
• Company Name: Avalign Technologies, Inc.
• Labeler DUNS: 792528510
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-02-22
• Public Version: 2
• Public Version Date: 2023-07-06
• Public Version Status: Update
• Public Device Record Key: dc54cc9a-6453-40b1-bb4b-3b869b5bfe4d

Device Description

Fox Eye Shield,

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
HOY	Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)	Ophthalmic	886.4750	1

GMDN Terms

Code	Name	Definition	Implantable	Status
63491	Eye irrigation shield, reusable	A device intended to be used with an eye irrigation kit/system to direct irrigation solution to the surface of the eye and allow the solution to gently lavage the surface of the eye (e.g., to flush the cornea and sclera of irritating particulates/chemicals). It is a curved/cup-like device, intended to be placed over the eye surface, with a port to allow entry of the irrigation solution; it may include a length of tubing. It is intended to be connected to an irrigation solution reservoir/pump. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00190776360238	GS1

Customer Contacts

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