DEVICE: PhotoFix Decellularized Bovine Pericardium (00877234000539)
Device Identifier (DI) Information
PhotoFix Decellularized Bovine Pericardium
PFP1X6
In Commercial Distribution
PFP1X6
Artivion, Inc.
PFP1X6
In Commercial Distribution
PFP1X6
Artivion, Inc.
Decellularized Bovine Pericardium
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 |
---|---|
PSQ | Intracardiac Patch Or Pledget, Biologically Derived |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Special Storage Condition, Specify: Do not place the pericardium in areas where significant temperature fluctuations occur. |
Storage Environment Temperature: between 5 and 25 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Width: 1 Centimeter |
Length: 6 Centimeter |
Device Record Status
a2a3b29f-7cae-4b1c-ab9c-9b8aea0d59a9
February 19, 2024
4
January 19, 2018
February 19, 2024
4
January 19, 2018
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
[?]
800-438-8285
xxx@xx.xx
xxx@xx.xx