{"publicDeviceRecordKey":"9dafc27b-d1ea-458f-8deb-05cb588b43e0","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2022-01-24T00:00:00.000Z","devicePublishDate":"2022-01-14T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08437018413010","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"SENTINELLA","versionModelNumber":"SENTINELLA 102","catalogNumber":"FP-0040","dunsNumber":"463337670","companyName":"GENERAL EQUIPMENT FOR MEDICAL IMAGING SA","deviceCount":1,"deviceDescription":"Sentinella 102 is a mobile gamma camera system which is intended for imaging the distribution of radionuclides in the human body by means of photon detection. It provides scintigraphic images of specific parts of the body based on the detection of gamma rays emitted by the radioisotopes injected into patients.  Sentinella presents the following modalities:\n• Sentinella 102 (this record)\n• Sentinella 102 Horus","DMExempt":true,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":true,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K162052","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"40641","gmdnPTName":"Mobile gamma camera system","gmdnPTDefinition":"An assembly of mobile diagnostic devices designed to record, quantify, and analyse radionuclide emissions (primarily gamma rays) produced during the decay of radiopharmaceuticals or other radiation emitting materials injected into, or ingested by, a patient. It uses Anger or non-Anger detection methods and consists of an analogue or digital detector based nuclear medicine (NM) planar imaging system, a sodium iodide (Nal) crystal(s), a collimator and a set of photomultiplier tubes. Gamma rays pass through holes in the collimator causing light flashes within the crystal corresponding to the sites of origin in the body and the amplitude of the flash is calculated by a computer to create images.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"IYX","productCodeName":"Camera, Scintillation (Gamma)"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Height","size":{"unit":"Centimeter","value":"185"},"sizeText":null,"sizeString":"Height: 185 Centimeter"},{"sizeType":"Depth","size":{"unit":"Centimeter","value":"77"},"sizeText":null,"sizeString":"Depth: 77 Centimeter"},{"sizeType":"Width","size":{"unit":"Centimeter","value":"63"},"sizeText":null,"sizeString":"Width: 63 Centimeter"},{"sizeType":"Weight","size":{"unit":"Kilogram","value":"134"},"sizeText":null,"sizeString":"Weight: 134 Kilogram"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Handling Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"40"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"10"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Handling Environment Humidity","storageHandlingHigh":{"unit":"Percent (%) Relative Humidity","value":"70"},"storageHandlingLow":{"unit":"Percent (%) Relative Humidity","value":"30"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"55"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"-20"},"storageHandlingSpecialConditionText":null}]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}