{"publicDeviceRecordKey":"76c89988-3401-49e6-aeda-5c7c0209a307","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2020-05-18T00:00:00.000Z","devicePublishDate":"2020-05-08T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04046964588730","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"AESCULAP","versionModelNumber":"MA603R","catalogNumber":"MA603R","dunsNumber":"082594540","companyName":"AESCULAP, INC.","deviceCount":1,"deviceDescription":"HOUSE GELFOAM PRESS 12X16 178MM","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":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)282-9000","phoneExtension":null,"email":"GUDID.BBMUS_Service@bbraun.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"35970","gmdnPTName":"Dental irrigation/aspiration syringe","gmdnPTDefinition":"A hand-held manual dental device (a plunger-type syringe) designed to inject and/or aspirate a volume of solution into the working area in the oral cavity. It typically consists of a small syringe (e.g., 3 ml) and is used for washing and aspirating the pulp cavity and root canal to remove debris. It is hand-operated by the user who exerts a steady pressure on, e.g., thumb rings and/or swivel finger bars, which exerts pressure on the syringe plunger forcing the washing/rinsing fluids through an attached needle (e.g., a blunt or very fine needle) directly at the operative site. 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":[]}}