DEVICE: TiO2Mesh (EBCBMFP1010)

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Device Record History
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Device Identifier (DI) Information
TiO2Mesh
MFP101
In Commercial Distribution
MFP101
BioCer Entwicklungs-GmbH
EBCBMFP1010
HIBCC

1
315855531 *Terms of Use
TiO2Mesh surgical mesh implant for hernia repair made of 100% Polypropylene with titanium oxide surface coating. Size 6cm x 9cm / 2.4" x 3.6"
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Device Characteristics
MR Safe
No
Yes
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?
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., polycarbonate (PC), 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 [?]
K113311 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
No Device Sizes
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Device Record Status
74cf2e95-4248-43b4-aa37-c4b27436c304
August 18, 2025
6
March 15, 2018
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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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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