Epsilon USA

Basic Information

• Brand Name: Epsilon USA
• Primary DI: G346EB23I0
• Version / Model: EB-23i
• 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: 2024-10-11
• Public Version: 1
• Public Version Date: 2024-10-21
• Public Version Status: New
• Public Device Record Key: 77337e95-4f3c-4dfd-bc23-2d4389ef5999

Device Description

Ogawa Bi-Manual Irrigator 23G 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
HOE	Caliper, Ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
35787	Ophthalmic calliper	A hand-held manual ophthalmic measuring instrument consisting of two legs hinged at one end and designed to measure the diameter, length, angles, and thicknesses of the eye. Some types, known as a blepharometer, can be used to measure the thickness of the eyelid and the force of the lid closure.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G346EB23I0	HIBCC

Customer Contacts

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