{"publicDeviceRecordKey":"85503814-ddad-492a-8851-abc9d5657184","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2022-09-29T00:00:00.000Z","devicePublishDate":"2020-05-08T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04046964586705","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"AESCULAP","versionModelNumber":"MA375R","catalogNumber":"MA375R","dunsNumber":"082594540","companyName":"AESCULAP, INC.","deviceCount":1,"deviceDescription":"MC GEE Micro Ear Needle, 20 °, angled, 6 3/8\", (162 mm), non-sterile, reusable","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":"33452","gmdnPTName":"Tonsil dissector, reusable","gmdnPTDefinition":"A hand-held surgical instrument, usually spoon-shaped or rounded at the working end, used during the dissection of the tonsils during ear/nose/throat (ENT) surgery. It can be designed in several configurations, e.g., with a shaft that terminates at the distal end with a rounded, curved or angled tip, or it may be double-ended. The tip may be pointed, flat, sharp or blunt and angled or straight from the shaft and may or may not be serrated. It is made of high-grade stainless steel, available in various shapes and sizes, and may include suction capabilities. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KBR","productCodeName":"NEEDLE, TONSIL SUTURING"}]},"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":[]}}