Colors in Optics

Basic Information

• Brand Name: Colors in Optics
• Primary DI: 00781268852005
• Version / Model: COLORS CXB117 - OX (+3.75)
• Catalog Number: CXB117 - OX (+3.75)
• Company Name: Colors In Optics, Ltd.
• Labeler DUNS: 060215290
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-10-26
• Public Version: 1
• Public Version Date: 2022-11-03
• Public Version Status: New
• Public Device Record Key: 2c22de60-fd3b-4d92-a30d-8f93926bae6b

Device Description

Readers

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
HOI	Spectacle, magnifying	Ophthalmic	886.5840	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42832	Magnifying spectacles	A device that consists of a spectacle frame with convex lenses intended to enlarge text/images for a visually impaired patient/person. It is made of plastic material or glass within a plastic or metal frame.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00781268852005	GS1

Customer Contacts

• Phone: [phone] ext. 328
• Email: [email protected]