{"publicDeviceRecordKey":"ee37ca57-cd19-40ee-88e5-8f1821c34143","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2025-10-06T00:00:00.000Z","devicePublishDate":"2025-09-26T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"G767WM0101420","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Alira Medical Devices","versionModelNumber":"WM01-0142","catalogNumber":"WM01-0142","dunsNumber":"112837961","companyName":"Alira Medical Devices, LLC","deviceCount":1,"deviceDescription":"UNIVERSAL GRAFT GUN | 1cc to 20cc\n","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1 818-614-4592","phoneExtension":null,"email":"info@alirameddevices.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"44869","gmdnPTName":"Orthopaedic graft inserter, reusable","gmdnPTDefinition":"A hand-held manual surgical instrument designed to push a cartilage or bone graft into a position from which the graft can be delivered into a chondral defect [e.g., during anterior cruciate ligament (ACL) reconstruction surgery]. This device is available in a variety of designs, such as a plunger made of high-grade materials [e.g., stainless steel or titanium (Ti)] used to advance the graft down its tubular-shaped holder or possibly a bone graft funnel and into place; it is also available in a variety of sizes. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"LXH","productCodeName":"Orthopedic Manual Surgical Instrument"}]},"deviceSizes":{"deviceSize":[]},"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":[]}}