Perceval S Single Use Accessory Kit

Basic Information

• Brand Name: Perceval S Single Use Accessory Kit
• Primary DI: 08022057015228
• Version / Model: ICV1346
• Company Name: CORCYM SRL
• Labeler DUNS: 441454802
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-06
• Public Version: 7
• Public Version Date: 2023-02-08
• Public Version Status: Update
• Public Device Record Key: 5749c60c-0b68-4cab-975b-c8ed422711c9

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
58707	Self-expandable heart valve prosthesis post-dilation balloon catheter	A shaft with an inflatable balloon at its distal end intended to be used during open cardiovascular surgery to dilate the inflow ring of a sutureless cardiac (heart) valve prosthesis, after its implantation and self expansion, to facilitate valve sealing and anchoring. It typically includes a Luer connector at the proximal end and is available in a variety of sizes to fit with the valve sizes. This is a single-use device.	No	Active
58987	Self-expandable heart valve bioprosthesis collapsing tool, single-use	A dedicated, manually-operated device designed to reduce the diameter of a self-expanding cardiac valve prosthesis during open and/or transcatheter cardiovascular surgery so the collapsed valve can be mounted onto a dedicated holder or catheter to facilitate implantation. It is available in a variety of designs. This is a single-use device.	No	Active
47680	Heart valve prosthesis holder, single-use	A hand-held, non-powered, invasive surgical instrument designed to hold a cardiac (heart) valve prosthesis or a cardiac annuloplasty ring at, or in proximity to, its site of implantation during surgery. It includes an implant mounting/containing feature and a handle; implantable devices are not included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08022057015228	GS1