{"publicDeviceRecordKey":"7b458c20-7ea2-479e-b124-40f1d54f1b98","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2023-01-09T00:00:00.000Z","devicePublishDate":"2022-12-30T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00810071635465","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00810071634819","pkgQuantity":8,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"CS"},{"deviceId":"00810071634819","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00810071634161","pkgQuantity":6,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Box"},{"deviceId":"00810071634161","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Curaplex","versionModelNumber":"1121-36557","catalogNumber":"1121-36557","dunsNumber":"070556204","companyName":"BOUND TREE MEDICAL, LLC","deviceCount":1,"deviceDescription":"Curaplex Conforming Stretch Gauze Bandage, Sterile 6in , 6rl/bx 8bx/cs","DMExempt":true,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":true,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"58964","gmdnPTName":"Non-adhesive device retention bandage","gmdnPTDefinition":"A piece or roll of material intended to be wrapped around a part of the body to secure a device (e.g., skin dressing, catheter, cannula) to the patient, without adhering to or compressing the body. It may be made from a variety or combination of materials, including cotton, viscose, and plastic (e.g., polyamide), and some types are cohesive (i.e., the bandage adheres to itself but not to other surfaces); it is used in various clinical specialties (e.g., dermatology, general/plastic surgery). This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"FQM","productCodeName":"BANDAGE, ELASTIC"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Ethylene Oxide"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}