Physio Flex Annuloplasty Ring

Basic Information

• Brand Name: Physio Flex Annuloplasty Ring
• Primary DI: 00690103206234
• Version / Model: 5300
• Catalog Number: 5300M38
• Company Name: Edwards Lifesciences LLC
• Labeler DUNS: 134139174
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-02-27
• Public Version: 2
• Public Version Date: 2021-02-05
• Public Version Status: Update
• Public Device Record Key: f06311d9-7a4c-45fd-af8a-ff9c131c611b

Device Description

Physio Flex Annuloplasty Ring

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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• 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
KRH	Ring, Annuloplasty	Cardiovascular	870.3800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
45577	Mitral annuloplasty ring	A circular band intended to be implanted in the heart to support a mitral valve annulus for the reconstruction and/or remodelling of an insufficient and/or stenotic mitral valve. It is typically mounted on a disposable holder assembly or preloaded in a disposable delivery system to enable it to maintain its shape and aid in its implantation with sutures or anchors. The device may be semi-rigid or flexible and may include metallic, polymeric, and/or textile materials; it is available in various sizes.	No	Obsolete
45578	Mitral/tricuspid annuloplasty ring	A circular band intended to be implanted in the heart to support a mitral/tricuspid valve annulus for the reconstruction and/or remodelling of insufficient and/or stenotic mitral and tricuspid valves. It is typically mounted on a disposable holder assembly or preloaded in a disposable delivery system to enable it to maintain its shape and aid in its implantation with sutures or anchors. The device may be semi-rigid or flexible and may include metallic, polymeric, and/or textile materials; it is available in various sizes.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00690103206234	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K192762	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			MEASUREMENT OF THE INTER-COMMISSURAL DISTANCE AND HEIGHT AND/OR SURFACE AREA OF THE ANTERIOR LEAFLET 38 MILLIMETERS

Storage Conditions

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