{"publicDeviceRecordKey":"b20fd8f5-f4f7-4a32-b9cd-65e64c8afdda","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2022-09-16T00:00:00.000Z","devicePublishDate":"2020-08-27T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"ESAM2991070","deviceIdType":"Direct Marking","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"ESAM2991071","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"STOMA®","versionModelNumber":"2991.07","catalogNumber":"2991.07","dunsNumber":"318268125","companyName":"Storz am Mark GmbH","deviceCount":1,"deviceDescription":"p.i.c.-tray, 180x86x30mm, with 2teflon racks and holder, for 7 instr.","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+49746592600","phoneExtension":null,"email":"sam@stoma.de"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"12143","gmdnPTName":"Instrument tray, reusable","gmdnPTDefinition":"A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"FSM","productCodeName":"TRAY, SURGICAL, INSTRUMENT"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Moist Heat or Steam Sterilization"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}