{"publicDeviceRecordKey":"6a74befa-9762-4298-87d8-34ccac6b4a04","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2024-09-02T00:00:00.000Z","devicePublishDate":"2018-09-11T00:00:00.000Z","deviceCommDistributionEndDate":"2021-02-02T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00821925018976","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Gyrus ACMI","versionModelNumber":"231014","catalogNumber":null,"dunsNumber":"007198742","companyName":"Gyrus ACMI, LLC","deviceCount":1,"deviceDescription":"GUTHRIE HOOK, SMALL, EBONY","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"65538","gmdnPTName":"Hand-held endoscopic retractor, reusable","gmdnPTDefinition":"A hand-held manual surgical instrument intended to be used to enable retraction of tissues during endoscopic/laparoscopic surgery. It consists of a handle with a slender body connected at the distal end to a retracting mechanism (e.g., inflatable/folding paddle, fan-like spreading mechanism, retracting hook). It is intended to be introduced through a laparoscopic port or endoscopic channel; it is not intended for wound retraction or for tissue cutting. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"LRC","productCodeName":"INSTRUMENT, ENT MANUAL SURGICAL"}]},"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":[]}}