HAART

Basic Information

• Brand Name: HAART
• Primary DI: 10857160006284
• Version / Model: 300-21US
• Catalog Number: 300-21US
• Company Name: Corcym Inc.
• Labeler DUNS: 112833663
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-05-15
• Public Version: 6
• Public Version Date: 2023-06-19
• Public Version Status: Update
• Public Device Record Key: e1a50e04-3cf0-4a64-96fb-9491d242cfbd

Device Description

Aortic Annuloplasty Device

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 Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• 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
PST	Aortic Annuloplasty Ring	Cardiovascular	870.3800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47931	Aortic annuloplasty ring	A circular band intended to be implanted in the heart during open heart surgery to support an aortic valve annulus for the reconstruction and/or remodelling of an insufficient aortic valve. It is typically mounted on a disposable holder assembly to enable it to maintain its shape and aid in its implantation, which may involve a specialized handle, with sutures. The device may be semi-rigid or flexible and may include metallic, polymeric, and/or textile materials; it is available in various sizes.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10857160006284	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K163608	000