DEVICE: Epic™ (05414734055598)

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Device Identifier (DI) Information

Epic™
Mitral
E100-29M-00
ST. JUDE MEDICAL, INC.
05414734055598
GS1
1
No description.
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Device Characteristics

MR Conditional
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
Mitral heart valve bioprosthesis A sterile xenograft (e.g., porcine or bovine heart valve) intended to be implanted in a patient during open heart surgery to repair or replace a dysfunctional mitral heart valve. It is processed to render the tissue in the valve non-viable; it may be tissue only, or tissue attached to a metal or synthetic polymer framework. The device is typically used to treat acquired or congenital valvular disease.
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FDA Product Code

[?]
Product Code Product Code Name
LWR heart-valve, non-allograft tissue
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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
Storage Environment Temperature: between 5 and 25 Degrees Celsius
Special Storage Condition, Specify: Store the valve in the upright position. If temperature indicator is Red, do not use.
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Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 29 Millimeter
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Device Status

In Commercial Distribution
September 23, 2014

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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

[?]
No
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
+1(855)478-5833
customerservice@sjm.com
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