Post Op Spectacle Fitover, Tinted

GUDID 00818806020425

Post Op Spectacle Fitover, Tinted, Large

RXSIGHT, INC.

Tinted spectacle lens, non-prescription

• Primary Device ID: 00818806020425
• NIH Device Record Key: c86a81f7-f111-41fa-b6d1-ddf6fbb1e519
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Post Op Spectacle Fitover, Tinted
• Version Model Number: 62013-004
• 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	00818806020425 [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, Tinted]

• 00818806020449: Post Op Spectacle Fitover, Tinted, Small
• 00818806020432: Post Op Spectacle Fitover, Tinted, Xtra Large
• 00818806020425: Post Op Spectacle Fitover, Tinted, Large
• 00818806020418: Post Op Spectacle Fitover, Tinted, Medium-Large
• 00818806020401: Post Op Spectacle Fitover, Tinted, Medium
• 00818806020395: Post Op Spectacle Fitover, Tinted, Medium-Small