{"publicDeviceRecordKey":"a84a7faa-5edf-41cb-ac51-cf3530195117","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2021-10-25T00:00:00.000Z","devicePublishDate":"2018-09-28T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08033945938703","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"08033945938567","pkgQuantity":2,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"carton box"},{"deviceId":"08033945938567","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"08033945938420","pkgQuantity":5,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"carton box"},{"deviceId":"08033945938420","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Single use Surgical Optical Fiber","versionModelNumber":"EMP-FBX272HS","catalogNumber":null,"dunsNumber":"436045833","companyName":"QUANTA SYSTEM SPA","deviceCount":1,"deviceDescription":"Single use Surgical Optical Fiber ø 272µm. Distributed by Olympus Surgical Technologies America.Gyrus ACMI, Inc.","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47785","gmdnPTName":"Urogenital surgical laser system beam guide, single-use","gmdnPTDefinition":"A flexible, probe-like device intended to be connected to a surgical laser system to invasively direct and deliver laser energy for urogenital surgical applications, typically to haemostatically cut, coagulate, and vaporize prostate tissue to treat benign prostatic hyperplasia (BPH), and/or to treat bladder, urethral, ureteral conditions (e.g., tumours, condylomas) or gynaecological disorders; it is not intended for other surgical applications. It is typically made of fibreoptic materials or fused silica and contains an invasive laser-firing distal end which may be available in a variety of configurations. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GEX","productCodeName":"Powered Laser Surgical Instrument"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}