AccessGUDID - DEVICE: Physio Flex Annuloplasty Ring (00690103206227)

GUDID

Device Identifier (DI) Information

Brand Name: Physio Flex Annuloplasty Ring
Version or Model: 5300
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5300M36
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103206227
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: Physio Flex Annuloplasty Ring

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
66338	Mitral/tricuspid annuloplasty ring, open-surgery	A circular band intended to be implanted in the heart during open heart surgery to support a mitral or tricuspid valve annulus for the reconstruction and/or remodelling of insufficient and/or stenotic mitral or 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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KRH	Ring, Annuloplasty

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K192762	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in a cool, dry place.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: MEASUREMENT OF THE INTER-COMMISSURAL DISTANCE AND HEIGHT AND/OR SURFACE AREA OF THE ANTERIOR LEAFLET 36 MILLIMETERS

Device Record Status

Public Device Record Key: 05021fc8-ea63-4d4c-93b1-7832a4e8d58e
Public Version Date: June 20, 2024
Public Version Number: 3
DI Record Publish Date: February 27, 2020