PERCEVAL S

Basic Information

• Brand Name: PERCEVAL S
• Primary DI: 08022057014849
• Version / Model: ICV1236
• 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: 6
• Public Version Date: 2023-02-08
• Public Version Status: Update
• Public Device Record Key: d396137e-abd7-4985-8de7-ad5b198bff13

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: 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
LWR	heart-valve, non-allograft tissue	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
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

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08022057014849	GS1

Premarket Submissions

Submission Number	Supplement Number
P150011	000