{"publicDeviceRecordKey":"f3649b49-dd42-450a-ac14-3e948fcb5e71","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2023-11-03T00:00:00.000Z","devicePublishDate":"2019-01-09T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"EAMITRI20700","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Wi-3 Arm","versionModelNumber":"TRI2070","catalogNumber":"TRI2070","dunsNumber":"303655286","companyName":"AMI Agency for Medical Innovations GmbH","deviceCount":1,"deviceDescription":"The Wi-3 Arm is used to fix the outer (white) HAL-RAR sleeve in place to enhance gradual opening of the RAR window when mucopexy is performed, allowing the surgeon, the nurse or any assistant to comfortably hold the system in position.\nThe Wi-3 HAL-RAR System (HAL - Hemorrhoidal Artery Ligation, RAR - Recto Anal Repair) is a Bluetooth-enabled, pulsed Doppler, ultrasound system intended to be used for detecting hemorrhoidal arteries, to manually ligate these arteries (HAL), and subsequently carry out a mucopexy of hemorrhoidal tissue prolapse (RAR) if necessary. ","DMExempt":true,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"44311","gmdnPTName":"Noninvasive vascular ultrasound system","gmdnPTDefinition":"An electrically-powered device assembly consisting of a control unit and an attached probe or interchangeable probes, designed to noninvasively locate and assess the extent of vascular (venous and arterial) flow restriction (e.g., clots, stenosis, mechanical damage) by measuring blood flow rate using ultrasound/Doppler/transit time technology. It may also be used to detect the foetal heartbeat.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"IYN","productCodeName":"System, Imaging, Pulsed Doppler, Ultrasonic"},{"productCode":"FHN","productCodeName":"Ligator, Hemorrhoidal"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Atmospheric Pressure","storageHandlingHigh":{"unit":"KiloPascal","value":"106"},"storageHandlingLow":{"unit":"KiloPascal","value":"50"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Storage Environment Humidity","storageHandlingHigh":{"unit":"Percent (%) Relative Humidity","value":"75"},"storageHandlingLow":{"unit":"Percent (%) Relative Humidity","value":"10"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"60"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"-20"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Handling Environment Atmospheric Pressure","storageHandlingHigh":{"unit":"KiloPascal","value":"106"},"storageHandlingLow":{"unit":"KiloPascal","value":"70"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Handling Environment Humidity","storageHandlingHigh":{"unit":"Percent (%) Relative Humidity","value":"75"},"storageHandlingLow":{"unit":"Percent (%) Relative Humidity","value":"30"},"storageHandlingSpecialConditionText":null},{"storageHandlingType":"Handling Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"35"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"10"},"storageHandlingSpecialConditionText":null}]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Moist Heat or Steam Sterilization"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}