AccessGUDID - DEVICE: GEOFORM ANNULOPLASTY RING WITH HOLDER

GUDID

Device Identifier (DI) Information

Brand Name: GEOFORM ANNULOPLASTY RING WITH HOLDER - MITRAL
Version or Model: 4200
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4200M26
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103166507
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?	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?
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 [?]
Premarket Submission Number Not Available/Not Released

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: SURFACE OF THE ANTERIOR LEAFLET, 26 MM

Device Record Status

Public Device Record Key: eb1241c4-b7d4-4afc-8cee-4b52650c7b44
Public Version Date: February 05, 2021
Public Version Number: 3
DI Record Publish Date: September 24, 2015