Optego

Basic Information

• Brand Name: Optego
• Primary DI: 00360843007773
• Version / Model: 94270
• Company Name: Optego Vision USA Inc.
• Labeler DUNS: 835541145
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-01-04
• Public Version: 1
• Public Version Date: 2024-01-12
• Public Version Status: New
• Public Device Record Key: 1d5ad51e-ba0c-438c-a634-809aa473dc4a

Device Description

Optego Prism Flipper, 1^in/1^out

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
HPC	Set, Lens, Trial, Ophthalmic	Ophthalmic	886.1405	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64350	Vision testing/training flipper	A device in the form of flipper lenses (two lenses on either side of a rotatable stem) intended to be used for the diagnosis and treatment of ophthalmic accommodation disorders. It consists of binocular spherical plus/minus lenses that can quickly be flipped from plus to minus, and which can be used by a healthcare professional for diagnosis or by a patient for self-training. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00360843007773	GS1