Optego

Basic Information

• Brand Name: Optego
• Primary DI: 00360843009975
• Version / Model: 9350004
• Company Name: Optego Vision USA Inc.
• Labeler DUNS: 835541145
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-29
• Public Version: 1
• Public Version Date: 2023-09-06
• Public Version Status: New
• Public Device Record Key: 84a936a8-78c8-4b05-bbc5-35fe17cec5de

Device Description

Optego Prism, 4 Diopter

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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HKT	Prism, Fresnel, Ophthalmic	Ophthalmic	886.1655	1

GMDN Terms

Code	Name	Definition	Implantable	Status
32718	Fresnel prism	A thin plastic sheet with embossed rulings, which provides the optical effect of a prism, intended to be applied to spectacle lenses to give a prismatic effect typically to manage strabismus or other eye muscle dysfunction. The device may also be temporarily applied to spectacle lenses to determine how a patient might respond to prismatic power in their eye glasses.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00360843009975	GS1