EZ-TRI-3600

Basic Information

• Brand Name: EZ-TRI-3600
• Primary DI: 00850038195564
• Version / Model: EZ-TRI-3600
• Company Name: U.S. OPHTHALMIC, L.L.C.
• Labeler DUNS: 166760392
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-19
• Public Version: 1
• Public Version Date: 2025-02-27
• Public Version Status: New
• Public Device Record Key: a386c27f-4c8b-4d3d-8c44-5feccec0a6e3

Device Description

3.5V Bivalve Nasal Speculum EZ-TRI-3600

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• 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
HJN	Transilluminator, Battery-Powered	Ophthalmic	886.1945	1

GMDN Terms

Code	Name	Definition	Implantable	Status
34174	ENT transilluminator	A hand-held instrument intended to be used to illuminate sinus tissue during an ear/nose/throat (ENT) procedure to render the tissue translucent for examination. It is connected through a light cable, that may or may not be part of the device, to a light source that generates the light. Its exterior is typically made of high-grade stainless steel; it has a fibreoptic bundle core that conducts the light to the target site. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850038195564	GS1