UNITY

Basic Information

• Brand Name: UNITY
• Primary DI: 00380650008053
• Version / Model: 00380650008053
• Catalog Number: 8065000805
• Company Name: Alcon Laboratories, Inc.
• Labeler DUNS: 008018525
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-08
• Public Version: 1
• Public Version Date: 2025-04-16
• Public Version Status: New
• Public Device Record Key: 42099a27-cd17-4c99-8d4d-8f809897126e

Device Description

25+ UNITY TOTALPLUS™ Combined Procedure Pack, CVS ES HyperVit™ 30K, Straight, Nano, Tipless

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: Yes
• 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: Yes
• 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
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	Ophthalmic	886.4150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45150	Ophthalmic surgical procedure kit, non-medicated, single-use	A collection of various ophthalmic surgical instruments and the necessary materials intended to be used to perform an ophthalmic surgical procedure; it is not comprised exclusively of dedicated implantation tools and it does not contain any pharmaceuticals. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10380650008050	GS1	Box	6	In Commercial Distribution
Primary	00380650008053	GS1