{"publicDeviceRecordKey":"e2033119-625d-4cf1-a226-a8abe6c8367d","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2023-02-15T00:00:00.000Z","devicePublishDate":"2023-02-07T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"G346ECF14SS0","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Epsilon USA","versionModelNumber":"ECF-14SS","catalogNumber":null,"dunsNumber":"917922762","companyName":"EPSILON EYE CARE PRIVATE LIMITED","deviceCount":1,"deviceDescription":"Colibri .12 1x2 Teeth Forceps with Tying Platform Castroviejo Handle (108 mm overall) Stainless Steel\nColibri .20 1x2 Teeth Forceps with Tying Platform Castroviejo Handle (108 mm overall) Stainless Steel\nColibri .30 1x2 Teeth Forceps with Tying Platform Castroviejo Handle (108 mm overall) Stainless Steel\nColibri .50 1x2 Teeth Forceps with Tying Platform Castroviejo Handle (108 mm overall) Stainless Steel","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":[{"phone":"(909)984-4614","phoneExtension":null,"email":"epsilonusa1@gmail.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"62674","gmdnPTName":"Ophthalmic soft-tissue manipulation forceps, tweezers-like, reusable","gmdnPTDefinition":"A hand-held manual surgical instrument designed to facilitate the grasping, manipulation, or clamping of, and/or removal of foreign bodies from, ophthalmic soft-tissues (ocular tissues, eyelids), and may be pointed for capsulorhexis. It has a conventional (self-opening) or reverse-action (self-closing) tweezers-like design with variously designed tips, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles); it is not probe-like in design (i.e., not cannulated). It is typically made of metal, available in various sizes, and may have carbide inserts at the working end. This is a reusable device intended to be sterilized prior to use.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HNR","productCodeName":"Forceps, Ophthalmic"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Ethylene Oxide","Dry Heat Sterilization","Moist Heat or Steam Sterilization"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}