Epsilon USA

Basic Information

• Brand Name: Epsilon USA
• Primary DI: G346ED570
• Version / Model: ED-57
• 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: 2023-01-05
• Public Version: 1
• Public Version Date: 2023-01-13
• Public Version Status: New
• Public Device Record Key: 521b6772-e1e6-42b2-a3a2-4f1890651e97

Device Description

Eye Scissors Straight Ring Handle 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: No
• 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
HNF	Scissors, Ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13489	Ophthalmic suture scissors	A hand-held ophthalmic surgical instrument used to cut suture during eye surgery. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the fine blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and is available in various designs and sizes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	G346ED570	HIBCC

Customer Contacts

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