DEVICE: Trifecta™ (05415067018236)
Device Identifier (DI) Information
Trifecta™
TFGT-25A
In Commercial Distribution
TFGT-25A
ST. JUDE MEDICAL, INC.
TFGT-25A
In Commercial Distribution
TFGT-25A
ST. JUDE MEDICAL, INC.
Aortic Pericardial Bioprosthetic Heart Valve with Glide Technology
Device Characteristics
MR Conditional | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
60242 | Aortic heart valve bioprosthesis |
A xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair or replace a dysfunctional aortic heart valve. It is processed to render the tissue in the valve non-viable; it may be tissue only, or tissue attached to a metal or synthetic polymer framework. The device is typically used to treat acquired or congenital valvular disease.
|
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 [?] |
---|---|
P100029 | 021 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store the valve in the upright position. Do not use the valve if shipping temperature indicators on the product carton have turned red. |
Storage Environment Temperature: between 5 and 25 Degrees Celsius |
Storage Environment Temperature: between 41 and 77 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
Outer Diameter: 25 Millimeter |
Device Record Status
e0fc3190-aafa-4da4-9678-4f5588221834
July 26, 2023
5
April 27, 2016
July 26, 2023
5
April 27, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(855)478-5833
customerservice@sjm.com
customerservice@sjm.com