Cor-Valv Atrial Retractor Cables with Fitting

Basic Information

• Brand Name: Cor-Valv Atrial Retractor Cables with Fitting
• Primary DI: 00817121000198
• Version / Model: 1011180
• Catalog Number: 1011180
• Company Name: Coroneo Inc
• Labeler DUNS: 255276362
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-28
• Public Version: 2
• Public Version Date: 2023-03-01
• Public Version Status: Update
• Public Device Record Key: 28ece483-476d-4dfb-994a-550ed06bb06c

Device Description

The Cor-Valv Cable is intended to be used with the corresponding CORONEO Cor-Valv system retractor for retraction of heart tissue during cardiac surgery. This product is provided sterile in a sealed package, and consists one(1) cable that is single-use and disposable held by a plastic insert.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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: Yes
• 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
GAD	Retractor	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46774	Surgical retractor/retraction system blade, reusable	A distal component of a surgical retraction system, surgical retractor, and/or surgical instrument assist arm system designed to function as a parting edge to separate the margins of a wound/incision during a surgical procedure. It is intended to be attached to the frame (e.g., mounting ring/bar) of a surgical retraction system, or may be fixed onto a retractor handle; it does not include a handle. It is a metal device, sometimes referred to as a variable or vario retractor blade when assembled with a separate retractor handle, because it is available in a variety of lengths and sizes. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10817121000195	GS1	Box	10	In Commercial Distribution
Primary	00817121000198	GS1

Customer Contacts

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