{"publicDeviceRecordKey":"487afe1d-a080-41be-89f8-0cc994fa95db","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2025-06-24T00:00:00.000Z","devicePublishDate":"2016-09-24T00:00:00.000Z","deviceCommDistributionEndDate":"2016-09-24T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"20884521189215","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"10884521189218","pkgQuantity":6,"pkgDiscontinueDate":"2016-09-24","pkgStatus":"Not in Commercial Distribution","pkgType":"CASE"},{"deviceId":"10884521189218","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Syneture","versionModelNumber":"US1663","catalogNumber":null,"dunsNumber":"058614483","companyName":"Covidien LP","deviceCount":1,"deviceDescription":"Custom Suture Pack,(1) 88863129-51;(2) 88863251-51;(2) CLS-953;(1) S-176;(1) S-195;(1) S-317;(1) SL-692;(1) SL-696;(1) VP-521-X;(2) VP-522-X;(1) VP-556-X;(1) VP-557-X;(1) VP-558-X;(3) VS-845","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":true,"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(508)261-8000","phoneExtension":null,"email":"covidien.udi@covidien.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"13892","gmdnPTName":"Suture kit, medicated","gmdnPTDefinition":"A collection of sterile instruments, dressings, and pharmaceuticals necessary to perform a suturing procedure. It typically includes a disinfectant, needles and various threads (sutures used to join the edges of a wound or incision by stitching), drapes, swabs, needle holder, and other single-use disposable devices. This device may be used in a wide variety of clinical settings and some types may be used for the removal of sutures. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"OVN","productCodeName":"Suture kit"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Handling Environment Temperature","storageHandlingHigh":{"unit":"Degrees Fahrenheit","value":"130"},"storageHandlingLow":{"unit":"Degrees Fahrenheit","value":""},"storageHandlingSpecialConditionText":null}]},"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":[]}}