Optego

Basic Information

• Brand Name: Optego
• Primary DI: 00360843006929
• Version / Model: 983561
• Company Name: Optego Vision USA Inc.
• Labeler DUNS: 835541145
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-01
• Public Version: 1
• Public Version Date: 2024-02-09
• Public Version Status: New
• Public Device Record Key: 47ab2796-d966-4d8a-b968-6e727a9d309a

Device Description

Post-Dilation Spectacles in polybags, Paper Temples, 25/box

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: Yes
• 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
46297	Tinted non-prescription spectacle lens	An ophthalmic lens made of a treated glass or plastic intended to be worn in front of the eyes to attenuate rays of light by absorption, reflection, or polarization to protect the eyes from bright light; it is neither intended to provide refractive corrections nor enhance colour discrimination and is not customized for a specific patient. This device may require cutting to enable it to be mounted into a selected spectacle frame for patient wear as sunglasses (non-prescription).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00360843006929	GS1