{"publicDeviceRecordKey":"f4671c5a-44a0-40a5-a56a-8648affb7b26","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2024-08-29T00:00:00.000Z","devicePublishDate":"2016-09-13T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00607915123710","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Kii Fios First Entry ","versionModelNumber":"CTF74","catalogNumber":null,"dunsNumber":"187129135","companyName":"APPLIED MEDICAL RESOURCES CORPORATION","deviceCount":1,"deviceDescription":"Trocar","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"1.949.713.8300","phoneExtension":null,"email":"contact@appliedmedical.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"42412","gmdnPTName":"Laparoscopic access cannula, single-use","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 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 additionally be intended for thoracoscopy whereby the valve may not be required. 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. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GCJ","productCodeName":"Laparoscope, General \u0026 Plastic Surgery"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Millimeter","value":"100"},"sizeText":null,"sizeString":"Length: 100 Millimeter"},{"sizeType":"Lumen/Inner Diameter","size":{"unit":"Millimeter","value":"12"},"sizeText":null,"sizeString":"Lumen/Inner Diameter: 12 Millimeter"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}