Bausch + Lomb

Basic Information

• Brand Name: Bausch + Lomb
• Primary DI: 00757770473946
• Version / Model: AI-28
• Company Name: Bausch & Lomb Incorporated
• Labeler DUNS: 196603781
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-25
• Public Version: 2
• Public Version Date: 2022-12-08
• Public Version Status: Update
• Public Device Record Key: 20b84fb5-8a76-4adb-ba72-089f7b7a75cd

Device Description

Inserter

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KYB	Lens, Guide, Intraocular	Ophthalmic	886.4300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47725	Manual intraocular lens injector, single-use	A hand-held manual ophthalmic surgical instrument designed to expel (launch) a prepared (folded) intraocular lens (IOL) from an attached IOL insertion cartridge into the anterior or posterior chamber of the eye during ophthalmic implantation surgery. It has a central plunger that is activated by a precise mechanism (e.g., a screw thread) and a mechanism at the distal end to hold/grip the insertion cartridge; it is typically made of plastic materials. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00757770473946	GS1