{"publicDeviceRecordKey":"997dc05a-3bb4-4f92-b564-6a95cb237956","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2023-07-10T00:00:00.000Z","devicePublishDate":"2023-06-30T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"10845819001025","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00845819001028","pkgQuantity":10,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Carton"},{"deviceId":"00845819001028","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Disposable Instruments ","versionModelNumber":"4017Y","catalogNumber":null,"dunsNumber":"194121018","companyName":"OASIS MEDICAL, INC.","deviceCount":1,"deviceDescription":"Irrigating Cystotome (F-SL Curve), 27g x 5/8” (Formed Short Length Curve)","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":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"9093055400","phoneExtension":null,"email":"customerservice@oasismedical.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46705","gmdnPTName":"Ophthalmic irrigation/infusion/aspiration cannula, non-illuminating, single-use","gmdnPTDefinition":"A rigid or semi-rigid tube (non-illuminating) designed to be inserted into the eye to facilitate infusion, irrigation, and/or aspiration of fluids/gases during ophthalmic surgery (e.g., phacoemulsification, vitreoretinal surgery, sub-Tenon’s anaesthesia, capsule polishing). It is a single- or multi-lumen device, typically made of high-grade stainless steel, and may include a length of flexible tubing or a basic handle (without controls). It may be blunt, or include a sharp angled tip/hook (e.g., irrigating cystotome for capsulotomy), however it does not have a sharp bevelled end for initial puncture of the eye (i.e., not a needle). This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HNY","productCodeName":"Cystotome"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Radiation Sterilization"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}