RxSight Insertion Device

GUDID 00818806021019

RxSight Insertion Device (Single-Use)

RXSIGHT, INC.

Manual intraocular lens injector, single-use

• Primary Device ID: 00818806021019
• NIH Device Record Key: cbf09047-e9c2-47f0-8fe7-7b372e913776
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RxSight Insertion Device
• Version Model Number: 63002
• Company DUNS: 052054413
• Company Name: RXSIGHT, INC.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818806021019 [Unit of Use]
GS1	10818806021016 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231838

FDA Product Code

• MSS: Folders And Injectors, Intraocular Lens (Iol)

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-20
• Device Publish Date: 2024-11-12

Devices Manufactured by RXSIGHT, INC.

• 00818806020852 - Light Adjustable Lens (LAL): 2024-12-12 LAL+, Light Adjustable Lens, Sterile, Packaged, 3.0 Diopter
• 00818806020869 - Light Adjustable Lens (LAL): 2024-12-12 LAL+, Light Adjustable Lens, Sterile, Packaged, 2.0 Diopter
• 00818806020951 - Light Adjustable Lens (LAL): 2024-12-12 LAL+, Light Adjustable Lens, Sterile, Packaged, 1.0 Diopter
• 00818806021484 - Light Adjustable Lens (LAL): 2024-12-12 LAL+, Light Adjustable Lens, Sterile, Packaged, 0.0 Diopter
• 00818806021736 - Light Adjustable Lens (LAL): 2024-12-12 LAL+, Light Adjustable Lens, Sterile, Packaged, -1.0 Diopter
• 00818806021743 - Light Adjustable Lens (LAL): 2024-12-12 LAL+, Light Adjustable Lens, Sterile, Packaged, -2.0 Diopter
• 00818806021019 - RxSight Insertion Device: 2024-11-20RxSight Insertion Device (Single-Use)
• 00818806021019 - RxSight Insertion Device: 2024-11-20 RxSight Insertion Device (Single-Use)
• 00818806021378 - Light Adjustable Lens (LAL): 2023-05-09 LAL+, Light Adjustable Lens, Sterile, Packaged, 4.0 Diopter