Post Op Spectacle Fitover, Clear

GUDID 00818806020371

Post Op Spectacle Fitover, Clear, Xtra Large

RXSIGHT, INC.

Tinted spectacle lens, non-prescription Tinted non-prescription spectacle lens Tinted non-prescription spectacle lens Tinted non-prescription spectacle lens Tinted non-prescription spectacle lens Tinted non-prescription spectacle lens Tinted non-prescription spectacle lens Tinted non-prescription spectacle lens Tinted non-prescription spectacle lens Tinted non-prescription spectacle lens Tinted non-prescription spectacle lens Tinted non-prescription spectacle lens Tinted non-prescription spectacle lens Tinted non-prescription spectacle lens Tinted non-prescription spectacle lens Tinted non-prescription spectacle lens Tinted non-prescription spectacle lens Tinted non-prescription spectacle lens Tinted non-prescription spectacle lens Tinted non-prescription spectacle lens Tinted non-prescription spectacle lens Tinted non-prescription spectacle lens Tinted non-prescription spectacle lens Tinted non-prescription spectacle lens

• Primary Device ID: 00818806020371
• NIH Device Record Key: 2c92a68c-f5bc-489e-83cc-5b4f6ce564da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Post Op Spectacle Fitover, Clear
• Version Model Number: 62012-005
• Company DUNS: 052054413
• Company Name: RXSIGHT, INC.
• Device Count: 1
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• 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	00818806020371 [Primary]

FDA Product Code

• HQY: Sunglasses (Non-Prescription Including Photosensitive)

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: 2019-04-16
• Device Publish Date: 2019-04-08

On-Brand Devices [Post Op Spectacle Fitover, Clear]

• 00818806020388: Post Op Spectacle Fitover, Clear, Small
• 00818806020371: Post Op Spectacle Fitover, Clear, Xtra Large
• 00818806020364: Post Op Spectacle Fitover, Clear, Large
• 00818806020357: Post Op Spectacle Fitover, Clear, Medium-Large
• 00818806020340: Post Op Spectacle Fitover, Clear, Medium
• 00818806020333: Post Op Spectacle Fitover, Clear, Medium-Small