{"publicDeviceRecordKey":"9b0575c6-be62-4297-905b-1a4d06dc21c9","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2024-06-17T00:00:00.000Z","devicePublishDate":"2016-09-23T00:00:00.000Z","deviceCommDistributionEndDate":"2021-07-29T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"20681490171667","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00681490171663","pkgQuantity":200,"pkgDiscontinueDate":"2021-07-29","pkgStatus":"Not in Commercial Distribution","pkgType":"PK"},{"deviceId":"00681490171663","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Neuray®","versionModelNumber":"8004055","catalogNumber":null,"dunsNumber":"835465063","companyName":"MEDTRONIC XOMED, INC.","deviceCount":1,"deviceDescription":"PACKING 8004055 NEURAY 200PK 51X152MM","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)633-8766","phoneExtension":null,"email":"Corporate.UDI@medtronic.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K923027","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"38496","gmdnPTName":"Radiopaque woven surgical sponge","gmdnPTDefinition":"A non-medicated device made from woven gauze (e.g., cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"HBA","productCodeName":"NEUROSURGICAL PADDIE"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Millimeter","value":"152.0"},"sizeText":null,"sizeString":"Length: 152.0 Millimeter"},{"sizeType":"Width","size":{"unit":"Millimeter","value":"50.0"},"sizeText":null,"sizeString":"Width: 50.0 Millimeter"}]},"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}