COVERCLUDE OCCLUSION EYE PATCHES

Basic Information

• Brand Name: COVERCLUDE OCCLUSION EYE PATCHES
• Primary DI: 00850029104056
• Version / Model: 012
• Company Name: Fresnel Prism & Lens Company
• Labeler DUNS: 789337987
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 10
• Record Status: Published
• Publish Date: 2021-03-29
• Public Version: 5
• Public Version Date: 2021-06-28
• Public Version Status: Update
• Public Device Record Key: 5aa89223-0f06-49e9-ab9f-3ad24c856edb

Device Description

PACKET, JUNIOR, COVERCLUDE

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: 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: Yes
• 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	00850029104056	GS1
Unit of Use	00850029104490	GS1
Package	10850029104602	GS1	PACKETS of 10	5	In Commercial Distribution

Customer Contacts

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