{"publicDeviceRecordKey":"e3573b20-ee8b-4d15-9547-d81b41d81a96","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2022-12-26T00:00:00.000Z","devicePublishDate":"2022-12-18T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"40653160994160","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"10653160994169","pkgQuantity":20,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"CASE"},{"deviceId":"10653160994169","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Centurion Medical Products Corp","versionModelNumber":"CHT2110","catalogNumber":"CHT2110","dunsNumber":"025460908","companyName":"MEDLINE INDUSTRIES, INC.","deviceCount":1,"deviceDescription":"ED CLOSED CHEST (THORACOSTOMY)","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":true,"deviceCombinationProduct":true,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)633-5463","phoneExtension":null,"email":"customerservice@medline.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"44057","gmdnPTName":"General surgical procedure kit, medicated","gmdnPTDefinition":"A typically non-dedicated collection of various surgical instruments, sometimes with dressings and/or other materials, and that includes a pharmaceutical component, intended to be used during: 1) open abdominal surgery; 2) a range of open surgical procedures across multiple clinical specialties (non-dedicated); 3) non-orthopaedic trauma surgery; 4) minor dermatological surgery; or 5) cosmetic surgery below the head. As a kit that includes procedural devices, it is neither dedicated to surgical scrubbing, surgical patient preparation, nor anaesthesia, and is not a dedicated biopsy kit. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"OGR","productCodeName":"Ear, nose, and throat surgical tray"}]},"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,"premarketSubmissions":{"premarketSubmission":[]}}