EYEWEAR BY ROI SCARLETT ROSE

Basic Information

• Brand Name: EYEWEAR BY ROI SCARLETT ROSE
• Primary DI: 00748474332745
• Version / Model: 1
• Company Name: Eyewear By Roi, Limited
• Labeler DUNS: 177953189
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-20
• Public Version: 1
• Public Version Date: 2022-10-28
• Public Version Status: New
• Public Device Record Key: 2824f2f8-c2b9-44b0-8f00-bdf43e8f535f

Device Description

51-17-140 ROSE WITTNAUER

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
HQZ	Frame, spectacle	Ophthalmic	886.5842	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32816	Spectacle frame	An ophthalmic device designed to hold a pair of spectacle lenses in front of and close to the eyes of the user. It typically consists of a plastic or metallic frame that is supported by the nose and ears. The device may have a protective function (e.g., by including side shields).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00748474332745	GS1

Customer Contacts

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