{"publicDeviceRecordKey":"e627d296-8f11-43c1-a982-4a83363b767d","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2024-10-28T00:00:00.000Z","devicePublishDate":"2016-09-21T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"10381780093046","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Integra® MicroFrance®","versionModelNumber":"CEV416","catalogNumber":"CEV416","dunsNumber":"276593071","companyName":"INTEGRA MICROFRANCE","deviceCount":1,"deviceDescription":"Integra® MicroFrance® Flexible retractor, 5 mm diameter, 380 mm length","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"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)654-2873","phoneExtension":null,"email":"custsvcnj@integralife.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"58883","gmdnPTName":"Externally-anchored laparoscopic retractor","gmdnPTDefinition":"A non-sterile, intraoperative surgical instrument designed for use during laparoscopic procedures to provide hands-free retraction of lower abdominal, urogenital or pelvic structures. It is inserted into the abdominal cavity through a small dedicated incision and manoeuvred into place under direct laparoscopic vision to lift the urogenital structures, and then anchored external to the body to a fixation device typically attached to the operating table. It is typically made of metal (e.g., stainless steel) and is in the form of a rod shaped to form a saddle-shaped hook, and may be available in left and right configurations. This is a reusable device intended to be sterilized prior to use.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GCJ","productCodeName":"Laparoscope, general \u0026 plastic surgery"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Store in a clean, dry area"}]},"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":[]}}