{"publicDeviceRecordKey":"29019e2f-c850-4632-b74a-d0e10c7a110e","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2023-08-03T00:00:00.000Z","devicePublishDate":"2022-12-09T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"G346ES030","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Epsilon USA","versionModelNumber":"ES-03","catalogNumber":null,"dunsNumber":"917922762","companyName":"EPSILON EYE CARE PRIVATE LIMITED","deviceCount":1,"deviceDescription":"Iris Curved Scissor (95 mm overall) Titanium\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":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"(909)984-4614","phoneExtension":null,"email":"epsilonusa1@gmail.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"13489","gmdnPTName":"Ophthalmic suture scissors","gmdnPTDefinition":"A hand-held ophthalmic surgical instrument used to cut suture during eye surgery. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the fine blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and is available in various designs and sizes. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HNF","productCodeName":"Scissors, Ophthalmic"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Dry Heat Sterilization","Moist Heat or Steam Sterilization","Ethylene Oxide"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}