{"publicDeviceRecordKey":"ab7fb7f9-cda5-46f0-980d-00a0663836d1","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2023-08-03T00:00:00.000Z","devicePublishDate":"2022-10-14T00:00:00.000Z","deviceCommDistributionEndDate":"2023-02-26T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"10768455106957","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00768455106950","pkgQuantity":20,"pkgDiscontinueDate":"2023-02-26","pkgStatus":"Not in Commercial Distribution","pkgType":null},{"deviceId":"00768455106950","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"00768455179008","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"STOMAHESIVE","versionModelNumber":"021901","catalogNumber":null,"dunsNumber":"809784593","companyName":"CONVATEC, PURCHASING DEPARTMENT","deviceCount":5,"deviceDescription":"STOMAHESIVE WFR 10X10CM (1X5PK) STER US","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"+18004228811","phoneExtension":null,"email":"cic@convatec.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"31073","gmdnPTName":"Intestinal stoma shield/support belt, single-use","gmdnPTDefinition":"A non-sterile plate, typically with a waist belt for attachment, intended to be placed over an enteric stoma (surgically-created artificial opening between the intestines and the body surface through which bodily waste is drained) to protect it from harmful external influences (e.g., knocks, friction), to reduce the risk of stomal herniation, or to help maintain adhesion of the base plate to the skin. Also known as a stoma protector it is usually attached by the patient to the base plate/wafer that retains the stomal bag, or might be placed directly over the stomal opening when the bag is removed; it may in addition include an attachable ostomy bag protector. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EXE","productCodeName":"PROTECTOR, OSTOMY"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}