RxSight Injector Handpiece

GUDID 00818806020005

Injector Handpiece

RXSIGHT, INC.

Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable Manual intraocular lens injector, reusable

• Primary Device ID: 00818806020005
• NIH Device Record Key: 94b58811-bc23-4e3c-b613-d6586af278e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RxSight Injector Handpiece
• Version Model Number: 63001
• Company DUNS: 052054413
• Company Name: RXSIGHT, INC.
• Device Count: 1
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00818806020005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181401

FDA Product Code

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

Sterilization

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

[00818806020005]

Moist Heat or Steam Sterilization

[00818806020005]

Moist Heat or Steam Sterilization

[00818806020005]

Moist Heat or Steam Sterilization

[00818806020005]

Moist Heat or Steam Sterilization

[00818806020005]

Moist Heat or Steam Sterilization

[00818806020005]

Moist Heat or Steam Sterilization

[00818806020005]

Moist Heat or Steam Sterilization

[00818806020005]

Moist Heat or Steam Sterilization

[00818806020005]

Moist Heat or Steam Sterilization

[00818806020005]

Moist Heat or Steam Sterilization

[00818806020005]

Moist Heat or Steam Sterilization

[00818806020005]

Moist Heat or Steam Sterilization

[00818806020005]

Moist Heat or Steam Sterilization

[00818806020005]

Moist Heat or Steam Sterilization

[00818806020005]

Moist Heat or Steam Sterilization

[00818806020005]

Moist Heat or Steam Sterilization

[00818806020005]

Moist Heat or Steam Sterilization

[00818806020005]

Moist Heat or Steam Sterilization

[00818806020005]

Moist Heat or Steam Sterilization

[00818806020005]

Moist Heat or Steam Sterilization

[00818806020005]

Moist Heat or Steam Sterilization

[00818806020005]

Moist Heat or Steam Sterilization

[00818806020005]

Moist Heat or Steam Sterilization

[00818806020005]

Moist Heat or Steam Sterilization

[00818806020005]

Moist Heat or Steam Sterilization

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

Devices Manufactured by RXSIGHT, INC.

• 00818806021378 - Light Adjustable Lens (LAL): 2023-05-09 LAL+, Light Adjustable Lens, Sterile, Packaged, 4.0 Diopter
• 00818806021385 - Light Adjustable Lens (LAL): 2023-05-09 LAL+, Light Adjustable Lens, Sterile, Packaged, 5.0 Diopter
• 00818806021392 - Light Adjustable Lens (LAL): 2023-05-09 LAL+, Light Adjustable Lens, Sterile, Packaged, 6.0 Diopter
• 00818806021408 - Light Adjustable Lens (LAL): 2023-05-09 LAL+, Light Adjustable Lens, Sterile, Packaged, 7.0 Diopter
• 00818806021415 - Light Adjustable Lens (LAL): 2023-05-09 LAL+, Light Adjustable Lens, Sterile, Packaged, 8.0 Diopter
• 00818806021422 - Light Adjustable Lens (LAL): 2023-05-09 LAL+, Light Adjustable Lens, Sterile, Packaged, 9.0 Diopter
• 00818806021439 - Light Adjustable Lens (LAL): 2023-05-09 LAL, Sterile, Packaged, 5.0 Diopter
• 00818806021446 - Light Adjustable Lens (LAL): 2023-05-09 LAL+, Light Adjustable Lens, Sterile, Packaged, 11.0 Diopter