{"publicDeviceRecordKey":"34872b5e-bbf5-4f33-b493-5bc72df4272f","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2024-10-28T00:00:00.000Z","devicePublishDate":"2016-12-23T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"18033737710514","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"08033737710517","pkgQuantity":10,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":null},{"deviceId":"08033737710517","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope","versionModelNumber":"THD Surgy Mini Light - Scope Not Sterile","catalogNumber":"800108","dunsNumber":"338430324","companyName":"THD SPA","deviceCount":1,"deviceDescription":"The THD SURGY light-scope anoscope is a disposable medical device deemed for investigation of the anal canal.\nThe THD SURGY light-scope 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 SURGY light-scope anoscope is ready-to-use and does not need for other tools.\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"}]},"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":"FER","productCodeName":"Anoscope And Accessories"},{"productCode":"GCP","productCodeName":"Endoscope, Ac-Powered And Accessories"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"24"},"sizeText":null,"sizeString":"Outer Diameter: 24 Millimeter"},{"sizeType":"Length","size":{"unit":"Millimeter","value":"122.4"},"sizeText":null,"sizeString":"Length: 122.4 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,"premarketSubmissions":{"premarketSubmission":[]}}