Voss Coronary Bypass Sterile Marker

Basic Information

• Brand Name: Voss Coronary Bypass Sterile Marker
• Primary DI: 00811304020041
• Version / Model: 40149
• Company Name: VM CARDIO VASCULAR, INC.
• Labeler DUNS: 799240457
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-01-05
• Public Version: 4
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: 29bb4029-9240-446c-9ed1-32697c90e866

Device Description

Coronary Bypass Graft Marker (sterile)

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: No
• 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
KPK	Marker, Ostia, Aorto-Saphenous Vein	General, Plastic Surgery	878.4650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60867	Polymeric coronary bypass marker	A device intended to be implanted during coronary artery bypass graft surgery, at the point of the arterial anastomosis, to provide clear postsurgical radiographic verification of the arterial anastomosis. It is in the form of a synthetic polymer ring (e.g., silicone) impregnated with a metal [e.g., tungsten (W)] to aid visualization, and is compatible with the imaging system with which it is intended to be visualized/exposed [e.g., magnetic resonance imaging (MRI), fluoroscopy].	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00811304020041	GS1

Premarket Submissions

Submission Number	Supplement Number
K895369	000