I IMAGE

Basic Information

• Brand Name: I IMAGE
• Primary DI: 00193033013045
• Version / Model: 1019646-175.SAM
• Company Name: FGX INTERNATIONAL INC.
• Labeler DUNS: 062312087
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-06-22
• Public Version: 1
• Public Version Date: 2022-06-30
• Public Version Status: New
• Public Device Record Key: 2c3cc788-ab42-4bb5-9e96-d51e2380671d

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
HOI	Spectacle, magnifying	Ophthalmic	886.5840	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35065	Prescription spectacles	An ophthalmic device consisting of a spectacle frame with a pair of optical spectacle lenses (typically made of plastic or glass, also known as eyeglasses) designed to be worn in front of the user's eyes to provide refractive corrections to eyesight conditions such as presbyopia (the eye's diminished power of accommodation that occurs with ageing), or refractive ametropia (myopia, hyperopia and astigmatism). The lenses may be tinted (sunglasses) to protect the eyes from bright light and radiation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00193033013045	GS1

Customer Contacts

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