Spectacle Frame

GUDID 16974852470018

Luxin Optical (Shanghai) Co., Ltd.

Prescription spectacles Prescription spectacles Prescription spectacles Prescription spectacles Prescription spectacles Prescription spectacles Prescription spectacles Prescription spectacles Prescription spectacles Prescription spectacles Prescription spectacles Prescription spectacles Prescription spectacles Prescription spectacles Prescription spectacles Prescription spectacles Prescription spectacles 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