Constellation, Ultravit, TotalPlus, Engauge

Basic Information

• Brand Name: Constellation, Ultravit, TotalPlus, Engauge
• Primary DI: 00380657510658
• Version / Model: 8065751065
• Company Name: Alcon Laboratories, Inc.
• Labeler DUNS: 008018525
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-24
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 217ad57d-6081-428b-a2ec-1400644e69e0

Device Description

Constellation Vision System 5000 CPM UltraVit Probe Straight Endoilluminator 23 GA TotalPlus Combined Procedure Pak Engauge RFID 1.1 mm Tipless Anterior Kit

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: 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
HQC	Unit, phacofragmentation	Ophthalmic	886.4670	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45073	Phacoemulsification/vitrectomy system generator	A mains electricity (AC-powered) ophthalmic device, that is a component of a system, that generates the energies (e.g., ultrasonic, piezoelectric, high frequency current) delivered through handpieces/tips that are introduced through an incision(s) made in the eye, for the purposes of performing combined phacoemulsification and/or vitrectomy (the removal and replacement of cataracts and/or the vitreous in anterior and posterior segment surgical procedures). It will typically be activated by the surgeon using a foot-switch and may include an irrigation/suction system for the removal of debris, a tamponade system (e.g., silicone and air), a diathermy device, and an intraocular illuminator.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10380657510655	GS1	Box	6	In Commercial Distribution
Primary	00380657510658	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			23 Gauge