Epsilon USA

Basic Information

• Brand Name: Epsilon USA
• Primary DI: G346EC1150
• Version / Model: EC-1-15
• 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: 2025-06-26
• Public Version: 1
• Public Version Date: 2025-07-04
• Public Version Status: New
• Public Device Record Key: 45e2de16-ddff-4468-b584-806920f4cf10

Device Description

Desmarres Lid Retractor 15 mm Stainless Steel

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
HNI	Retractor, Ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35314	Periocular/lacrimal retractor, hand-held, reusable	A hand-held, non-self-retaining, ophthalmic surgical instrument intended to be used to separate periocular tissues and/or draw aside the margins of a periocular surgical wound during an ophthalmic intervention (e.g., eyelid retraction, lacrimal sac access). The instrument is typically designed with a shaped/hooked blade or flat plate (e.g., eyelid plate) with a handle/holding portion, and is usually made of metal. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G346EC1150	HIBCC

Customer Contacts

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