{"publicDeviceRecordKey":"4b14a365-181a-4006-9715-138256f0fe3d","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2024-09-25T00:00:00.000Z","devicePublishDate":"2016-09-27T00:00:00.000Z","deviceCommDistributionEndDate":"2024-09-24T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00817602020240","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00817602020233","pkgQuantity":96,"pkgDiscontinueDate":"2024-09-24","pkgStatus":"Not in Commercial Distribution","pkgType":"Case"},{"deviceId":"00817602020233","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Exact Medical Manufacturing, Inc.","versionModelNumber":"19104","catalogNumber":"19104","dunsNumber":"014464314","companyName":"EXACT MEDICAL MANUFACTURING, INC.","deviceCount":1,"deviceDescription":"Split Drape 60\" X 70\" (6\" X 21\" Split)-","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":true,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":true,"contacts":{"customerContact":[{"phone":"716-681-0866","phoneExtension":null,"email":"rdean@exactmm.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"47783","gmdnPTName":"Patient surgical drape, single-use","gmdnPTDefinition":"A noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KKX","productCodeName":"Drape, Surgical"}]},"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":[]}}