DISPOSABLE HANDLE FOR VALVES/SIZERS

Basic Information

• Brand Name: DISPOSABLE HANDLE FOR VALVES/SIZERS
• Primary DI: 00690103019247
• Version / Model: 1126
• Catalog Number: 1126
• 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: 2201995c-df83-4238-9608-71012d2f3695

Device Description

DISPOSABLE HANDLE FOR VALVES/SIZERS

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: Yes
• 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
DTI	Sizer, Heart-Valve, Prosthesis	Cardiovascular	870.3945	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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
Package	50690103019242	GS1	Case	10	In Commercial Distribution
Primary	00690103019247	GS1

Customer Contacts

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

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: STORE IN A COOL, DRY PLACE