DEVICE: GORE DUALMESH PLUS BIOMATERIAL (00733132601202)

Device Identifier (DI) Information

GORE DUALMESH PLUS BIOMATERIAL
1DLMCP203
In Commercial Distribution
1DLMCP203
W. L. Gore & Associates, Inc.
00733132601202
GS1

1
967358115 *Terms of Use
No description.
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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
Multi-purpose surgical mesh, synthetic polymer, non-bioabsorbable, antimicrobial A sterile, flat or three-dimensional (3-D), woven/knitted material made of non-bioabsorbable synthetic polymer(s) intended for multiple defective tissue repair applications at different anatomical zones (e.g., thoracic, abdominal) that includes an extra-abdominal application(s); it includes a pharmaceutical antibacterial substance/agent (e.g., chlorhexidine diacetate). It may also be used as a scaffold for tissue regeneration. Disposable devices associated with implantation may be included.
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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 [?]
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
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
Height: 2 Millimeter
Width: 20 Centimeter
Length: 30 Centimeter
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Device Record Status

c5a3c358-9d2b-4a24-83a4-3d47096ff214
March 29, 2018
2
March 07, 2016
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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
No
No CLOSE

Customer Contact

[?]
8005288763
mpdcustomercare@wlgore.com
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