Spectacle Lens

Basic Information

• Brand Name: Spectacle Lens
• Primary DI: 16974852470070
• Version / Model: LXPAC
• Company Name: Luxin Optical (Shanghai) Co., Ltd.
• Labeler DUNS: 527864061
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2023-03-09
• Public Version: 1
• Public Version Date: 2023-03-17
• Public Version Status: New
• Public Device Record Key: 1bb68be6-161e-49db-bad2-ebc8e46a6537

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
HQG	Lens, Spectacle, Non-Custom (Prescription)	Ophthalmic	886.5844	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
Unit of Use	06974852470073	GS1
Primary	16974852470070	GS1