DEVICE: GORE-TEX Soft Tissue Patch (00733132600571)

Device Identifier (DI) Information

GORE-TEX Soft Tissue Patch
140501001B
In Commercial Distribution
140501001B
W. L. Gore & Associates, Inc.
00733132600571
GS1

1
967358115 *Terms of Use
GORE-TEX SOFT TISSUE PATCH 5.0cmX10.0cmX1.0mm
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Device Characteristics

MR Safe
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. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
60300 Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable
An implantable material (e.g., flat sheet) made from a non-bioabsorbable synthetic polymer(s) [e.g., polyglycolic acid (PGA), polycarbonate (PC), polyglycolide or carbon fibres] intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]. Disposable devices associated with implantation may be supplied with the mesh.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
FTL Mesh, Surgical, Polymeric
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K963619 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: 5 Centimeter
Length: 10 Centimeter
Height: 1 Millimeter
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Device Record Status

f9ecce35-b847-47eb-b1b7-819d8739adf6
December 25, 2023
10
January 26, 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)

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

[?]
No
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
800-528-8763
mpdcustomercare@wlgore.com
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