OBTURATOR FOR MITRAL XENOGRAFT 35MM

Basic Information

• Brand Name: OBTURATOR FOR MITRAL XENOGRAFT 35MM
• Primary DI: 00690103019476
• Version / Model: 1162
• Catalog Number: 116235MM
• Company Name: Edwards Lifesciences LLC
• Labeler DUNS: 134139174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-04-03
• Public Version: 1
• Public Version Date: 2026-04-13
• Public Version Status: New
• Public Device Record Key: 54ba732b-dcc3-44f5-b2da-e9f333559fb7

Device Description

MITRAL TRUE-SIZE OBTURATOR F/USE W/1111 HDLE

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• 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
47684	Heart valve annulus sizer, reusable	A hand-held manual surgical instrument intended to be used during heart valve repair or replacement that enables evaluation of the valve opening (patent annulus) into which the appropriately sized annuloplasty ring or replacement valve will be implanted. It is typically available as a set of round tapered sizers in a range for the aortic, mitral, or tricuspid valve; it may include an attachable handle which may also be used to assist implantation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00690103019476	GS1

Customer Contacts

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