CONSTELLATION® ULTRAVIT® ENGAUGE®

Basic Information

• Brand Name: CONSTELLATION® ULTRAVIT® ENGAUGE®
• Primary DI: 00380657509508
• Version / Model: 8065750950
• Company Name: Alcon Laboratories, Inc.
• Labeler DUNS: 008018525
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-01-16
• Public Version: 2
• Public Version Date: 2022-01-24
• Public Version Status: Update
• Public Device Record Key: cfcb9ed9-0aae-4e45-a227-bbbd21e322c3

Device Description

25 GA ULTRAVIT® Vitrectomy Probe

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
MLZ	Vitrectomy, instrument cutter	Ophthalmic	886.4150	2

GMDN Terms

Code	Name	Definition	Implantable	Status
34125	Vitrectomy system handpiece	A holder for a detachable, micro-cutting tip that converts the energy (e.g., ultrasonic, piezoelectric) produced by a system generator into a mechanical oscillating-cutting action to remove (nibble away) vitreous humour (the jelly-like substance that fills the centre of the eye) during ophthalmic surgery. This device will typically be activated by the surgeon using a foot control and provide or support the irrigation/suction systems needed to supply replacement fluid and remove debris. The handpiece is typically designed in the form of a pen or pencil, and connected to the generator via a cable. This is a reusable device intended to be sterilized prior to use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10380657509505	GS1		6	In Commercial Distribution
Primary	00380657509508	GS1

Customer Contacts

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