CARBOMEDICS ANNULOFLEX

Basic Information

• Brand Name: CARBOMEDICS ANNULOFLEX
• Primary DI: 08022057013637
• Version / Model: AF-8
• Company Name: CORCYM SRL
• Labeler DUNS: 441454802
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-07-24
• Public Version: 5
• Public Version Date: 2023-02-08
• Public Version Status: Update
• Public Device Record Key: 60e995b7-136d-4475-b36c-1b2786b90d96

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: MR Safe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
KRH	RING, ANNULOPLASTY	Cardiovascular	870.3800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45578	Mitral/tricuspid annuloplasty ring	A circular band intended to be implanted in the heart to support a mitral/tricuspid valve annulus for the reconstruction and/or remodelling of insufficient and/or stenotic mitral and tricuspid valves. It is typically mounted on a disposable holder assembly or preloaded in a disposable delivery system to enable it to maintain its shape and aid in its implantation with sutures or anchors. The device may be semi-rigid or flexible and may include metallic, polymeric, and/or textile materials; it is available in various sizes.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08022057013637	GS1

Premarket Submissions

Submission Number	Supplement Number
K023185	000