{"publicDeviceRecordKey":"16253f30-b3d8-42d1-a5fe-ea3a6f7b2db9","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2020-11-11T00:00:00.000Z","devicePublishDate":"2020-11-03T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"04048817622745","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"ContexGel.sleeve","versionModelNumber":"30L50/L","catalogNumber":"30L50/L","dunsNumber":"317931954","companyName":"Streifeneder ortho.production GmbH","deviceCount":1,"deviceDescription":"ContexGel.sleeve, sand-coloured, knee sleeve, size L, length: 38,5 cm, one-piece knit cover, antibacterial finish","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":true,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"41536","gmdnPTName":"External limb prosthesis socket liner","gmdnPTDefinition":"A flexible device designed to be fitted inside the socket of an external upper or lower limb prosthesis to form an interface between the socket and the residual limb; it is intended to enable the residual limb to optimally fit the socket by coupling the two together mechanically and/or by pressure differential. It may be made of various textile or synthetic polymer materials (e.g., silicone, thermoplastic elastomer, polyurethane).","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"ISS","productCodeName":"Prosthesis, Thigh Socket, External Component"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"30L50/S: size S, length: 37 cm, dist.: 15-23 cm, prox.: 23-35 cm"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"30L50/M: size M, length: 37 cm, dist.: 21-31 cm, prox.: 29-44 cm"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"30L50/L: size L, length: 38,5 cm, dist.: 28-43 cm, prox.: 36-52 cm"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"30L50/XL: size XL, length: 38,5 cm, dist.: 34-48 cm, prox.: 42-58 cm"},{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"30L50/XXL: size XXL, length: 38,5 cm, dist.: 38-52 cm, prox.: 43-64 cm"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}