DEVICE: GORE PRECLUDE Pericardial Membrane (00733132601806)

Device Identifier (DI) Information

GORE PRECLUDE Pericardial Membrane
1PCM001
Not in Commercial Distribution
1PCM001
W. L. Gore & Associates, Inc.
00733132601806
GS1
April 16, 2025
1
967358115 *Terms of Use
PCM 7.0CM X 10.0CM X 0.1MM
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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?
36182 Pericardium prosthesis
An implantable synthetic material intended to be used in the repair of the pericardium (the double membranous, cone-shaped fibroserous sac enclosing the heart and the roots of the great blood vessels).
Active true
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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 [?]
K012098 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Width: 7 Centimeter
Length: 10 Centimeter
Height: 0 Millimeter
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Device Record Status

e5456356-5af8-45f8-a3ac-6c3ed84b5151
June 20, 2025
6
February 13, 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
HIBCC H3731PCM00136
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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(800)528-8763
mpdcustomercare@wlgore.com
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