DEVICE: PhotoFix Decellularized Bovine Pericardium (00877234000560)

Device Identifier (DI) Information

PhotoFix Decellularized Bovine Pericardium
PFP8X14
In Commercial Distribution
PFP8X14
Cryolife, Inc.
00877234000560
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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

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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

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Storage and Handling
Storage Environment Temperature: between 5 and 25 Degrees Celsius
Special Storage Condition, Specify: Do not place the pericardium in areas where significant temperature fluctuations occur.
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Clinically Relevant Size

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Size Type Text
Width: 8 Centimeter
Length: 14 Centimeter
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Device Record Status

cfad3770-dfd3-4b5c-ab8a-cd63fb354d9a
February 05, 2021
2
March 29, 2019
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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

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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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