{"publicDeviceRecordKey":"b03255dc-72c5-494c-b047-aceb137258de","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2024-10-28T00:00:00.000Z","devicePublishDate":"2016-09-30T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"18033737710460","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"08033737710463","pkgQuantity":10,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":null},{"deviceId":"08033737710463","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"28033737710467","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"08033737710463","pkgQuantity":25,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":null}]},"brandName":"THD disposable sterile and not sterie Ano-, Procto- Rectoscopes and Light-scope","versionModelNumber":"THD Light - Scope LED Medium Rectoscope with inflation bulb Not Sterile","catalogNumber":"800100","dunsNumber":"338430324","companyName":"THD SPA","deviceCount":1,"deviceDescription":"The Light-Scope LED rectoscope is a disposable medical device deemed for investigation of the anal canal and of the distal region of the sigma.\nThe Light-Scope LED rectoscope combines in a single device a magnifier lens and a powerful, fully integrated, LED light source, in order to have a clear and detailed vision of the inspection field.\nThe Light-Scope LED rectoscope is ready-to-use and it also available with an inflating included.\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":"GCP","productCodeName":"Endoscope, Ac-Powered And Accessories"},{"productCode":"FER","productCodeName":"Anoscope And Accessories"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Millimeter","value":"190"},"sizeText":null,"sizeString":"Length: 190 Millimeter"},{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"20"},"sizeText":null,"sizeString":"Outer Diameter: 20 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":[]}}