{"publicDeviceRecordKey":"5cf5d3dd-2a6a-465d-b9e2-804629213aa4","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2019-09-09T00:00:00.000Z","devicePublishDate":"2016-12-09T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"10612479214306","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"20612479214310","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"10612479214306","pkgQuantity":12,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Box"}]},"brandName":"McKesson","versionModelNumber":"SY497GX","catalogNumber":null,"dunsNumber":"023904428","companyName":"MCKESSON MEDICAL-SURGICAL INC.","deviceCount":1,"deviceDescription":"SUTURE *3-0 PGA/PCL 18 DSM19\n","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":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K000037","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"17246","gmdnPTName":"Polyglyconate suture","gmdnPTDefinition":"A sterile, single-strand (monofilament), synthetic, bioabsorbable thread made from polyglyconate (prepared from a copolymer of glycolic acid and trimethylene carbonate) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues (especially in paediatric cardiovascular surgeries). It may include an attached needle intended to be disposed of after single use. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Obsolete"}]},"productCodes":{"fdaProductCode":[{"productCode":"GAM","productCodeName":"Suture, Absorbable, Synthetic, Polyglycolic Acid"}]},"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}