DEVICE: PhotoFix (B040PFP6X81)

Device Identifier (DI) Information

PhotoFix
PFP6x8
In Commercial Distribution
N/A
GENESEE BIOMEDICAL, INC.
B040PFP6X81
HIBCC

1
939872651 *Terms of Use
Decellularized Bovine Pericardium
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
Yes

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 A sterile 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

[?]
Product Code Product Code Name
DXZ Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
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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
Storage Environment Temperature: between 41 and 77 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

73869f95-0ea8-41ce-a380-3941cdca297c
March 29, 2018
2
February 01, 2017
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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)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
303 777-3000
info@geneseebiomedical.com
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