pioli™ IOL Delivery System

GUDID 10814899027041

Single-use, Sterile Intraocular Lens Injector Only for the Insertion of IOL Models Validated for Use with this Device as Indicated in the IOL Approved Labeling

AST PRODUCTS, INC.

Manual intraocular lens injector, single-use

• Primary Device ID: 10814899027041
• NIH Device Record Key: 937f382f-bd51-42fb-b580-4f2e444c77af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: pioli™ IOL Delivery System
• Version Model Number: PIOLI-D
• 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: false
• Expiration Date: true
• 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	00814899027044 [Unit of Use]
GS1	10814899027041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172228

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-12-08
• Device Publish Date: 2018-09-14

Devices Manufactured by AST PRODUCTS, INC.

• 10814899027003 - lioli™ IOL Delivery System: 2022-12-08 Single-use, Sterile Intraocular Lens Injector Only for the Insertion of IOL Models Validated for Use with this Device as Indicat
• 10814899027010 - lioli™ IOL Delivery System: 2022-12-08 Single-use, Sterile Intraocular Lens Injector Only for the Insertion of IOL Models Validated for Use with this Device as Indicat
• 10814899027027 - lioli™ IOL Delivery System: 2022-12-08 Single-use, Sterile Intraocular Lens Injector Only for the Insertion of IOL Models Validated for Use with this Device as Indicat
• 10814899027041 - pioli™ IOL Delivery System: 2022-12-08Single-use, Sterile Intraocular Lens Injector Only for the Insertion of IOL Models Validated for Use with this Device as Indicated in the IOL Approved Labeling
• 10814899027041 - pioli™ IOL Delivery System: 2022-12-08 Single-use, Sterile Intraocular Lens Injector Only for the Insertion of IOL Models Validated for Use with this Device as Indicat
• 00814899027167 - bioli™ IOL Delivery System: 2022-10-11 The bioli™ IOL Delivery System is a single-use, sterile device intended to insert an approved single-piece foldable acrylic in
• 00814899027075 - bioli™ IOL Delivery System: 2020-12-15 The bioli™ IOL Delivery System is a single-use, sterile device intended to insert an approved single-piece foldable acrylic in
• 00814899027129 - bioli™ IOL Delivery System: 2020-12-15 The bioli™ IOL Delivery System is a single-use, sterile device intended to insert an approved single-piece foldable acrylic in
• 00814899027136 - bioli™ IOL Delivery System: 2020-12-15 The bioli™ IOL Delivery System is a single-use, sterile device intended to insert an approved single-piece foldable acrylic in