I9011S

Basic Information

• Brand Name: I9011S
• Primary DI: 00844369016858
• Version / Model: 05-2135
• Company Name: Lenstec Barbados Inc
• Labeler DUNS: 860235001
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-06
• Public Version: 1
• Public Version Date: 2024-05-14
• Public Version Status: New
• Public Device Record Key: 048ab541-1b04-4af1-9995-0409b22286d1

Device Description

Push Injector, titanium

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MSS	Folders And Injectors, Intraocular Lens (Iol)	Ophthalmic	886.4300	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47724	Manual intraocular lens injector, reusable	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 lightweight metal materials [e.g., titanium (Ti)]. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00844369016858	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]