{"publicDeviceRecordKey":"039e5bf0-fedd-4777-add6-ad2a6e8c7c64","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2023-07-18T00:00:00.000Z","devicePublishDate":"2023-07-10T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08175700141017","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Needle Holders","versionModelNumber":"AS11-002T","catalogNumber":"AS11-002T","dunsNumber":"968368832","companyName":"AURORA SURGICAL, LLC","deviceCount":1,"deviceDescription":"Barraquer Needle Holder, Delicate Jaws 6mm, Straight Without Lock, 110mm, Titanium\n","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"63492","gmdnPTName":"Ophthalmic suture/needle passer","gmdnPTDefinition":"A hand-held manual ophthalmic surgical instrument designed for passing (driving) a suture needle with a pre-attached suture through ocular structures (e.g., ciliary sulcus) during an ophthalmic surgical procedure (e.g., securing the haptics of an intraocular lens during implantation). It is a syringe-like device with a distal tip and a manual needle-driving mechanism. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HNR","productCodeName":"Forceps, Ophthalmic"}]},"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":[]}}