{"publicDeviceRecordKey":"62aed90d-66b6-46ed-b9e1-f87439f9e813","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2018-07-06T00:00:00.000Z","devicePublishDate":"2017-01-18T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08033737712153","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"18033737712150","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"08033737712153","pkgQuantity":25,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":null}]},"brandName":"THD Bandy","versionModelNumber":"THD Bandy","catalogNumber":"800183","dunsNumber":"338430324","companyName":"THD SPA","deviceCount":1,"deviceDescription":"THD Bandy is a disposable suction ligator for the treatment of haemorrhoidal disease, ready to use. No cleaning or disinfection required.\nTHD Disposable comes in single packing (single use), including ligator and loading system.\nTHD Bandy connects to a suction system, while it is possible to control the quality of aspirated tissue, around which the elastic band will be released by pulling the trigger\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+390522634311","phoneExtension":null,"email":"Regulatory@thdlab.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K093497","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46878","gmdnPTName":"Haemorrhoid ligation set","gmdnPTDefinition":"A collection of sterile surgical instruments and materials used to locally occlude the blood flow to internal haemorrhoids for their removal. The collection typically includes a ligator preloaded with several ligatures (e.g., latex rubber bands) deployed to the haemorrhoids, an anoscope used to dilate the anus for internal access, and an obturator for insertion of the anoscope. After a ligature has been applied, the haemorrhoid will eventually necrose and pass out of the gut naturally. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"FHN","productCodeName":"Ligator, Hemorrhoidal"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Millimeter","value":"154"},"sizeText":null,"sizeString":"Length: 154 Millimeter"},{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"12.8"},"sizeText":null,"sizeString":"Outer Diameter: 12.8 Millimeter"}]},"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}