VISCOJECT 1.8 Injector set

Basic Information

• Brand Name: VISCOJECT 1.8 Injector set
• Primary DI: 07630055211941
• Version / Model: LP604350
• Catalog Number: LP604350
• Company Name: Medicel AG
• Labeler DUNS: 487158263
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-12-01
• Public Version: 1
• Public Version Date: 2023-12-11
• Public Version Status: New
• Public Device Record Key: 76d6e3bf-65ee-44f5-b78b-878f6b7ce69d

Device Description

Injectors and cartridges for the injection of intraocular lenses (IOL) into the eye during surgical procedures.

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
MSS	Folders And Injectors, Intraocular Lens (Iol)	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	07630055211941	GS1

Customer Contacts

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