DEVICE: PhotoFix Decellularized Bovine Pericardium (00877234000539)

Device Identifier (DI) Information

PhotoFix Decellularized Bovine Pericardium
PFP1X6
In Commercial Distribution
PFP1X6
Artivion, Inc.
00877234000539
GS1

1
119253177 *Terms of Use
Decellularized Bovine Pericardium
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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
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FDA Product Code

[?]
Product Code Product Code Name
PSQ Intracardiac Patch Or Pledget, Biologically Derived
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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
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Clinically Relevant Size

[?]
Size Type Text
Width: 1 Centimeter
Length: 6 Centimeter
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Device Record Status

a2a3b29f-7cae-4b1c-ab9c-9b8aea0d59a9
February 19, 2024
4
January 19, 2018
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
800-438-8285
xxx@xx.xx
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