{"publicDeviceRecordKey":"1e8b7aaa-52e6-4869-8ee6-bf7d4ab9da18","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2021-05-27T00:00:00.000Z","devicePublishDate":"2021-05-14T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"18056138586601","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"08056138586604","pkgQuantity":10,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":null},{"deviceId":"08056138586604","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Intro","versionModelNumber":"PT19140","catalogNumber":"PT19140","dunsNumber":"447228586","companyName":"M.D.L. S.R.L.","deviceCount":1,"deviceDescription":"COAXIAL INTRODUCER NEEDLE 19G X 140 mm","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Unsafe","rx":true,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"62257","gmdnPTName":"Orthopaedic coaxial injection applicator","gmdnPTDefinition":"A tubular device with a concentric dual-lumen and a plunger intended to be used during surgery for the percutaneous injection of therapeutic materials (e.g., biologics, bone void fillers, irrigation fluids) into a bone, having been passed over a guidewire to the injection site. Typically, the inner lumen is used for the guidewire and the outer lumen for injection of fluids aided by the plunger. The device is made of metal and/or polymer materials. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"MJG","productCodeName":"Device, Percutaneous, Biopsy"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Needle Gauge","size":{"unit":"Gauge","value":"19"},"sizeText":null,"sizeString":"Needle Gauge: 19 Gauge"},{"sizeType":"Length","size":{"unit":"Millimeter","value":"140"},"sizeText":null,"sizeString":"Length: 140 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":[]}}