Coronet

Basic Information

• Brand Name: Coronet
• Primary DI: 05060165015344
• Version / Model: 51-823
• Company Name: NETWORK MEDICAL PRODUCTS LIMITED
• Labeler DUNS: 458670304
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-08-07
• Public Version: 1
• Public Version Date: 2019-08-15
• Public Version Status: New
• Public Device Record Key: d40fd288-28de-4b26-a7c9-b5e3ded1f6f3

Device Description

EndoGlide Ultrathin

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HRH	Trephine, Manual, Ophthalmic	Ophthalmic	886.4350	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48161	Donor cornea delivery set	A collection of sterile devices designed to hold and deliver prepared donor endothelial tissue for transplantation into a recipient eye following the removal of Descemet's membrane and dysfunctional endothelium from the patient's cornea during ophthalmic surgery. It typically consists of a preparation base, a cartridge which holds the tissue in a double-coil preventing the surfaces/edges from folding and touching, and an introducer to manually position the cartridge from where the tissue is glided into the eye in correct orientation to unfold. This set is only used for partial replacement of dysfunctional corneal cell layers and not for total cornea replacement. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060165015344	GS1