DEVICE: SJM Tailor™ (05414734007696)
Device Identifier (DI) Information
SJM Tailor™
TARP-29
In Commercial Distribution
TARP-29
ST. JUDE MEDICAL, INC.
TARP-29
In Commercial Distribution
TARP-29
ST. JUDE MEDICAL, INC.
ANNULOPLASTY RING
Device Characteristics
MR Safe | |
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? |
---|---|---|---|---|
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 [?] |
---|---|
K014161 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Store in the double-barrier tray in a cool, dry place until needed |
Clinically Relevant Size
[?]Size Type Text |
---|
Outer Diameter: 29 Millimeter |
Device Record Status
53a896fe-07a4-4eaf-9806-2d2c673ea557
July 24, 2023
5
January 07, 2015
July 24, 2023
5
January 07, 2015
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