BLIS-X1

GUDID 00757770520183

BLIS IOL Delivery System – X1 Cartridge

Bausch & Lomb Incorporated

Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic Posterior-chamber intraocular lens, pseudophakic

• Primary Device ID: 00757770520183
• NIH Device Record Key: c7e08291-e7ec-436b-806c-6c8a5e8dbafb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BLIS-X1
• Version Model Number: BLIS-X1
• Company DUNS: 196603781
• Company Name: Bausch & Lomb Incorporated
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00757770520183 [Primary]

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: 2024-03-12
• Device Publish Date: 2024-03-04

Devices Manufactured by Bausch & Lomb Incorporated

• 00757770520183 - BLIS-X1: 2024-03-12BLIS IOL Delivery System – X1 Cartridge
• 00757770520183 - BLIS-X1: 2024-03-12 BLIS IOL Delivery System – X1 Cartridge
• 00757770523337 - BLIS-X0: 2024-03-12 BLIS IOL Delivery System – X0 Cartridge
• 00757770601745 - Optisol: 2024-03-12 CORNEAL STORAGE MEDIA (Box of 12)
• 00757770488964 - Cystalsert Delivery System: 2024-01-26 Inserter - Lens Delivery System
• 00757770529032 - Sofport Easy-Load Lens Delivery System EZ-24: 2024-01-26 Inserter - Lens Delivery System
• 10757770618887 - enVista Aspire toric IOL: 2023-11-27 enVista Aspire toric hydrophobic acrylic IOL (non-preloaded) +8.00D SE / +1.50D CYL
• 10757770618894 - enVista Aspire toric IOL: 2023-11-27 enVista Aspire toric hydrophobic acrylic IOL (non-preloaded) +8.50D SE / +1.50D CYL
• 10757770618900 - enVista Aspire toric IOL: 2023-11-27 enVista Aspire toric hydrophobic acrylic IOL (non-preloaded) +9.00D SE / +1.50D CYL