{"publicDeviceRecordKey":"0c746f5e-0397-478c-bf1d-5bbe754b5601","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2023-11-17T00:00:00.000Z","devicePublishDate":"2017-01-20T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"38033737710723","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"08033737710722","pkgQuantity":25,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":null},{"deviceId":"08033737710722","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"28033737710726","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"08033737710722","pkgQuantity":50,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":null},{"deviceId":"18033737710729","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"08033737710722","pkgQuantity":10,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":null}]},"brandName":"THD N-ano anoscope","versionModelNumber":"Anoscope N-Ano MAXI Bevelled","catalogNumber":"800166","dunsNumber":"338430324","companyName":"THD SPA","deviceCount":1,"deviceDescription":"The THD N-ano anoscope is a disposable medical device deemed for investigation of the anal canal.\nThe THD N-ano anoscope combines in a single device a light anoscope and a powerful, fully integrated, LED light source, in order to have a clear and detailed vision of the inspection field.\nThe THD N-ano anoscope is ready-to-use and does not need for other tools.","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":"K133687","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"44914","gmdnPTName":"Optical anoscope, single-use","gmdnPTDefinition":"An endoscope with a rigid inserted portion intended for the visual examination and treatment of the anus and rectum. It is inserted into the body through the anus during anoscopy. The inserted portion is short in length, though longer than a sphincteroscope, and large in diameter, and an obturator is typically inserted into its lumen to assist the insertion. The anatomical images are illuminated by a built-in or external light source and can be viewed by the user through relayed lens optics or direct vision. This device is typically used to examine/diagnose patients suffering pain in the rectum/anus, haemorrhoids, or anal fissures. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GCP","productCodeName":"Endoscope, Ac-Powered And Accessories"},{"productCode":"FER","productCodeName":"Anoscope And Accessories"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"26"},"sizeText":null,"sizeString":"Outer Diameter: 26 Millimeter"},{"sizeType":"Length","size":{"unit":"Millimeter","value":"110"},"sizeText":null,"sizeString":"Length: 110 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}