OPHELIA ROE

Basic Information

• Brand Name: OPHELIA ROE
• Primary DI: 00708820706293
• Version / Model: 10262677.FMR
• Company Name: FGX INTERNATIONAL INC.
• Labeler DUNS: 062312087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-28
• Public Version: 1
• Public Version Date: 2022-07-06
• Public Version Status: New
• Public Device Record Key: 7e0259e7-7d34-4102-99d3-8263aadef7b2

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Manufacturing Date: No
• 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
HQY	Sunglasses (non-prescription including photosensitive)	Ophthalmic	886.5850	1

GMDN Terms

Code	Name	Definition	Implantable	Status
39694	Tinted non-prescription spectacles	An optical device, commonly known as sunglasses, that consists of a spectacle frame or clips with a pair of tinted spectacle lenses (typically made of plastic or glass) designed to be worn in front of the eyes to attenuate light radiation by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00708820706293	GS1

Customer Contacts

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