{"publicDeviceRecordKey":"d5982d8d-4b55-47a5-a06c-ba4f653749b0","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2024-11-11T00:00:00.000Z","devicePublishDate":"2020-01-30T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"10848782004758","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00848782004751","pkgQuantity":12,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Box"},{"deviceId":"00848782004751","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Plain Gut 6-0  18\" PC-1 Conventional Cutting 3/8C 13mm","versionModelNumber":"B1916N","catalogNumber":"B1916N","dunsNumber":"812762226","companyName":"Surgical Specialties México, S. de R.L. de C.V.","deviceCount":1,"deviceDescription":"Plain Gut 6-0  18\" PC-1 Conventional Cutting 3/8C 13mm","DMExempt":true,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(877)991-1110","phoneExtension":null,"email":"service@surgicalspecialties.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"13898","gmdnPTName":"Catgut suture, plain","gmdnPTDefinition":"A single-strand (monofilament), natural, bioabsorbable thread composed mostly of collagen fibres derived from mammals (e.g., sheep or bovine intestines) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by enzymatic degradation. This is a single-use device.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GAL","productCodeName":"SUTURE, ABSORBABLE, NATURAL"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"6-0 USP"}]},"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":[]}}