AccessGUDID - DEVICE: CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING

GUDID

Device Identifier (DI) Information

Brand Name: CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING - MITRAL
Version or Model: 4400
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4400M36
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103020106
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
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.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KRH	RING, ANNULOPLASTY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K912554	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: ANTERIOR LEAFLET DIAMETER, 36 MM

Device Record Status

Public Device Record Key: 86db2246-c8e7-4b55-b895-e6d82c3d1fa6
Public Version Date: February 05, 2021
Public Version Number: 4
DI Record Publish Date: September 24, 2015