iLumin

Basic Information

• Brand Name: iLumin
• Primary DI: 00893872001608
• Version / Model: FI-200
• Catalog Number: 205000
• Company Name: Nova Eye, Inc.
• Labeler DUNS: 079755637
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-19
• Public Version: 1
• Public Version Date: 2024-07-29
• Public Version Status: New
• Public Device Record Key: 1d27262f-f054-42bf-a38a-4fbbb67021b7

Device Description

Optical Light Source: Fiberoptic Illuminator, Gen 2 iLumin series of revisions

Device Characteristics

• Single Use: No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MPA	Endoilluminator	Gastroenterology, Urology	876.1500	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65935	Ophthalmic procedural light source unit	An electrically-powered, noninvasive device designed to produce light of high intensity, often called cold light, for ophthalmic examination and procedure applications. It is designed as a portable unit with controls whereby light transmission occurs either directly or through a fibreoptic-light cable connecting this device to an attached device (e.g., fibreoptic probes and micro light-conducting ophthalmic instruments that provide intraocular illumination).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00893872001608	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K062259	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -30 – 50 Degrees Celsius
• Type: Storage Environment Temperature
• Temperature Range: -30 – 50 Degrees Celsius