TiO2Mesh - TiO2Mesh surgical mesh implant for hernia repair - BioCer Entwicklungs-GmbH

Duns Number:315855531

Device Description: TiO2Mesh surgical mesh implant for hernia repair made of 100% Polypropylene with titanium TiO2Mesh surgical mesh implant for hernia repair made of 100% Polypropylene with titanium oxide surface coating.Size 10cm x 15cm / 4" x 6"

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More Product Details

Catalog Number

MFP332

Brand Name

TiO2Mesh

Version/Model Number

MFP332

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Safe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K113311

Product Code Details

Product Code

FTL

Product Code Name

Mesh, Surgical, Polymeric

Device Record Status

Public Device Record Key

7b82ca87-98a1-48bd-a369-efda453fd8f0

Public Version Date

June 10, 2022

Public Version Number

5

DI Record Publish Date

March 15, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"BIOCER ENTWICKLUNGS-GMBH" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 16