TiO2Mesh MFP121

GUDID EBCBMFP1210

TiO2Mesh surgical mesh implant for hernia repair made of 100% Polypropylene with titanium oxide surface coating. Size 15cm x 15cm / 6" x 6"

BioCer Entwicklungs-GmbH

Abdominal hernia surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable

• Primary Device ID: EBCBMFP1210
• NIH Device Record Key: d18f934a-358f-4c61-b3a0-ca4ca3f914ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TiO2Mesh
• Version Model Number: MFP121
• Catalog Number: MFP121
• Company DUNS: 315855531
• Company Name: BioCer Entwicklungs-GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EBCBMFP1210 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113311

FDA Product Code

• FTL: Mesh, Surgical, Polymeric

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-11-08
• Device Publish Date: 2018-03-15

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