EYEWEAR BY ROI WOOTEN INDIGO

Basic Information

• Brand Name: EYEWEAR BY ROI WOOTEN INDIGO
• Primary DI: 07484745183236
• Version / Model: 1
• Company Name: Eyewear By Roi, Limited
• Labeler DUNS: 177953189
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-07-15
• Public Version: 2
• Public Version Date: 2022-10-17
• Public Version Status: Update
• Public Device Record Key: 71a18a93-db33-4a62-9012-54ecea9a825c
• Distribution End Date: 2022-10-15

Device Description

52-16-140 INDIGO COLOURS BY ALEXANDER JULIAN

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	07484745183236	GS1

Customer Contacts

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