Sharn Inc

Basic Information

• Brand Name: Sharn Inc
• Primary DI: 00817518022123
• Version / Model: S2020-E
• Catalog Number: S2020-E
• Company Name: Sharn Anesthesia
• Labeler DUNS: 107996118
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 50
• Record Status: Published
• Publish Date: 2018-11-16
• Public Version: 2
• Public Version Date: 2019-05-23
• Public Version Status: Update
• Public Device Record Key: 03101762-7ee1-4a4b-8280-3a7daf8e4c36

Device Description

EyeGard Extended Wear

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: 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
HOY	Shield, eye, ophthalmic (including sunlamp protective eyewear and post-mydriatic eyewear)	Ophthalmic	886.4750	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61490	Eye patch	A device intended to be used to close/cover one or both eyes, for the purpose of protecting the eye after a procedure or as part of an ophthalmic therapeutic intervention. It is made of a synthetic or biological material. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817518022123	GS1
Unit of Use	00817518022130	GS1

Customer Contacts

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