{"publicDeviceRecordKey":"a3c1e8b0-ede5-4f47-a558-1c14bfd35d9d","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2020-07-30T00:00:00.000Z","devicePublishDate":"2016-05-22T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04046963424732","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"AESCULAP","versionModelNumber":"EK036R","catalogNumber":"EK036R","dunsNumber":"315018218","companyName":"Aesculap AG","deviceCount":1,"deviceDescription":"TROCAR SLEEVE 12/110MM THREADED WITH TAP","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)282-9000","phoneExtension":null,"email":"GUDID.BBMUS_Service@bbraun.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"37148","gmdnPTName":"Laparoscopic access cannula, reusable","gmdnPTDefinition":"A single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is often provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. It is available in a variety of dimensions and/or designs. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GCJ","productCodeName":"Laparoscope, general \u0026 plastic surgery"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Diameter (mm) : 12.000 MM"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Working length (mm) : 110.000 MM"}]},"environmentalConditions":{"storageHandling":[]},"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":[]}}