AccessGUDID - DEVICE: EDWARDS MC3 TRICUSPID ANNULOPLASTY RING (00690103182279)

GUDID

Device Identifier (DI) Information

Brand Name: EDWARDS MC3 TRICUSPID ANNULOPLASTY RING
Version or Model: 4900T
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4900T28
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103182279
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: Edwards MC3 Tricuspid 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):	No
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 [?]
K020864	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: MEASUREMENT OF THE SEPTAL LEAFLET OR THE SURFACE OF THE ANTERIOR LEAFLET

Device Record Status

Public Device Record Key: 3784f236-dc08-467c-96c5-3c59093d64c8
Public Version Date: April 10, 2023
Public Version Number: 6
DI Record Publish Date: September 24, 2015