Leaflet Tester

Basic Information

• Brand Name: Leaflet Tester
• Primary DI: 00896208000269
• Version / Model: VT-100
• Company Name: Corcym Canada Corp
• Labeler DUNS: 204322622
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-20
• Public Version: 2
• Public Version Date: 2023-02-08
• Public Version Status: Update
• Public Device Record Key: 93e0deb4-01ac-4e5f-9d75-5979cc14cdca

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Radiation Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXN	PROBE, TEST, HEART-VALVE	Cardiovascular	870.4500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47469	Heart valve prosthesis tester, single-use	A sterile, pen-like device intended to be used to manually manipulate a heart valve prosthesis to perform an assessment of the valvular prosthesis (e.g., its ability to open and close) prior to implantation and/or when in situ. It typically has a handle made of plastic and a soft tip (e.g., made of rubber) to prevent damage of the valvular prosthesis. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00896208000269	GS1