HEART VALVE HANDLE ACCESSORY

Basic Information

• Brand Name: HEART VALVE HANDLE ACCESSORY
• Primary DI: 00690103019063
• Version / Model: 1111
• Catalog Number: 1111
• Company Name: Edwards Lifesciences LLC
• Labeler DUNS: 134139174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-10-18
• Public Version: 1
• Public Version Date: 2024-10-28
• Public Version Status: New
• Public Device Record Key: aba2ada6-c410-4462-84b8-54427b840452

Device Description

HDLE,MITRAL ST/STEEL F/USE W/ 6625 OR 9120R HEART VLV

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DTJ	Holder, Heart-Valve, Prosthesis	Cardiovascular	870.3935	1

GMDN Terms

Code	Name	Definition	Implantable	Status
31707	Heart valve prosthesis holder, reusable	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 reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00690103019063	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Store in a dry, cool place.