bioli™ IOL Delivery System

GUDID 00814899027129

The bioli™ IOL Delivery System is a single-use, sterile device intended to insert an approved single-piece foldable acrylic intraocular lens (IOL) into the human eye through an incision. The bioli™ IOL Delivery System is only for the insertion of Lenstec Softec I IOL and IOL models validated for use with this device as indicated in the approved IOL labeling.

AST PRODUCTS, INC.

Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use Manual intraocular lens injector, single-use

• Primary Device ID: 00814899027129
• NIH Device Record Key: 5950d6ca-4b70-4fb2-838c-432ef304f2bd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: bioli™ IOL Delivery System
• Version Model Number: BIOLI-C
• Company DUNS: 611655440
• Company Name: AST PRODUCTS, 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: 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	00814899027129 [Unit of Use]
GS1	10814899027126 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200057

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: 2020-12-15
• Device Publish Date: 2020-12-07

On-Brand Devices [bioli™ IOL Delivery System]

• 00814899027136: The bioli™ IOL Delivery System is a single-use, sterile device intended to insert an approved
• 00814899027129: The bioli™ IOL Delivery System is a single-use, sterile device intended to insert an approved
• 00814899027075: The bioli™ IOL Delivery System is a single-use, sterile device intended to insert an approved
• 00814899027167: The bioli™ IOL Delivery System is a single-use, sterile device intended to insert an approved