PERCEVAL S

Basic Information

• Brand Name: PERCEVAL S
• Primary DI: 18022057015034
• Version / Model: ICV1268
• Company Name: CORCYM SRL
• Labeler DUNS: 441454802
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 5
• Record Status: Published
• Publish Date: 2016-06-06
• Public Version: 4
• Public Version Date: 2023-02-08
• Public Version Status: Update
• Public Device Record Key: 5b17950b-8d62-445a-93d6-0fc77196a517

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
60835	Heart valve prosthesis holder safety clip	A sterile device intended to be attached to a heart valve prosthesis holder during open surgical implantation of a self-expandable heart valve bioprosthesis, to position, secure, and prevent accidental release of the heart valve prosthesis holder’s holding mechanism (e.g., holding sheath). It is typically a plastic attachment with the appropriate size, shape and flexibility. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	18022057015034	GS1
Unit of Use	08022057015037	GS1

Premarket Submissions

Submission Number	Supplement Number
P150011	000