Spectacle Frame

Basic Information

• Brand Name: Spectacle Frame
• Primary DI: 16974852470018
• Version / Model: LXGL
• 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: 46c8eeae-f2e0-435d-b3bf-bc119c20d8a8

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: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: Yes

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HQZ	Frame, Spectacle	Ophthalmic	886.5842	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	16974852470018	GS1
Unit of Use	06974852470011	GS1