DEVICE: SJM™ (05414734054881)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
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? |
---|---|---|---|---|
35273 | Cardiovascular patch, animal-derived |
An implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a patch made of, or coated/impregnated with, materials of animal origin (e.g., porcine, bovine, or equine pericardium/collagen), that is typically implanted with sutures.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DXZ | PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K963967 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Atmospheric Pressure: between 25.33 and 101.33 KiloPascal |
Handling Environment Atmospheric Pressure: between 25.33 and 101.33 KiloPascal |
Handling Environment Temperature: between 0 and 45 Degrees Celsius |
Special Storage Condition, Specify: Do not use if package is damaged. Do not resterilize. |
Storage Environment Temperature: between 5 and 25 Degrees Celsius |
Handling Environment Humidity: between 0 and 100 Percent (%) Relative Humidity |
Storage Environment Humidity: between 0 and 100 Percent (%) Relative Humidity |
Storage Environment Temperature: between 41 and 77 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
Length: 5 Centimeter |
Width: 4 Centimeter |
Device Record Status
0cfa42e9-83ac-4fc0-9ee9-68bb459c950b
February 05, 2021
5
April 19, 2016
February 05, 2021
5
April 19, 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