Spectacle Frame

GUDID 16974852470018

Luxin Optical (Shanghai) Co., Ltd.

Prescription spectacles

• Primary Device ID: 16974852470018
• NIH Device Record Key: 46c8eeae-f2e0-435d-b3bf-bc119c20d8a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Spectacle Frame
• Version Model Number: LXGL
• Company DUNS: 527864061
• Company Name: Luxin Optical (Shanghai) Co., Ltd.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974852470011 [Unit of Use]
GS1	16974852470018 [Primary]

FDA Product Code

• HQZ: Frame, Spectacle

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-17
• Device Publish Date: 2023-03-09

Devices Manufactured by Luxin Optical (Shanghai) Co., Ltd.

• 06974852470189 - Sunglasses: 2023-03-20
• 16974852470018 - Spectacle Frame: 2023-03-17
• 16974852470018 - Spectacle Frame: 2023-03-17
• 06974852470073 - Spectacle Lens: 2023-03-17
• 06974852470127 - Reading glasses: 2023-03-17