Epsilon USA

Basic Information

• Brand Name: Epsilon USA
• Primary DI: G346EB03AS0
• Version / Model: EB-03AS
• Company Name: EPSILON EYE CARE PRIVATE LIMITED
• Labeler DUNS: 917922762
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-02-23
• Public Version: 1
• Public Version Date: 2024-03-04
• Public Version Status: New
• Public Device Record Key: b3aaaac0-e812-4876-b6ab-4b8e29032d4f

Device Description

Bi-Manual Aspirator Sand Blasted Tip 22G Titanium

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Dry Heat Sterilization, Moist Heat or Steam Sterilization, Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HMX	Cannula, Ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
17899	Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, reusable	A rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing. It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). 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
Primary	G346EB03AS0	HIBCC

Customer Contacts

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