{"publicDeviceRecordKey":"74cf2e95-4248-43b4-aa37-c4b27436c304","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2025-08-18T00:00:00.000Z","devicePublishDate":"2018-03-15T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"EBCBMFP1010","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"TiO2Mesh","versionModelNumber":"MFP101","catalogNumber":"MFP101","dunsNumber":"315855531","companyName":"BioCer Entwicklungs-GmbH","deviceCount":1,"deviceDescription":"TiO2Mesh surgical mesh implant for hernia repair made of 100% Polypropylene with titanium oxide surface coating.\nSize 6cm x 9cm / 2.4\" x 3.6\"\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"MR Safe","rx":true,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K113311","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"60300","gmdnPTName":"Extra-gynaecological surgical mesh, synthetic polymer, non-bioabsorbable","gmdnPTDefinition":"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.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"FTL","productCodeName":"Mesh, Surgical, Polymeric"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}