AccessGUDID - DEVICE: MITROFLOW VALSALVA CONDUIT (08022057014931)

GUDID

Device Identifier (DI) Information

Brand Name: MITROFLOW VALSALVA CONDUIT
Version or Model: MVC28
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Corcym Canada Corp

Primary DI Number: 08022057014931
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 204322622 *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):	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?
60350	Aortic open-surgery heart valve bioprosthesis/synthetic polymer aorta graft	An implantable xenograft (e.g., porcine or bovine heart valve) fitted with a length of synthetic polymer blood vessel (vascular graft) intended to be implanted in the heart during open heart surgery to simultaneously replace a dysfunctional aortic heart valve and repair/replace a damaged or diseased ascending aorta (e.g., in cases of aneurysm, dissection or dilatation). It is processed to render the tissue in the valve non-viable while the attached synthetic blood vessel is designed to conform to the aortic root anatomy.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LWR	heart-valve, non-allograft tissue

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
No Device Sizes

Device Record Status

Public Device Record Key: 37cb94f9-a452-40a6-b92f-e6c561c9597f
Public Version Date: May 30, 2025
Public Version Number: 8
DI Record Publish Date: September 22, 2014