{"publicDeviceRecordKey":"2a0ec20f-aac5-46f4-9619-ea2b3bb654a9","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2022-06-10T00:00:00.000Z","devicePublishDate":"2016-09-21T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"M84946763","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"M84946760","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Hobbs Single Cleaning Brush","versionModelNumber":"4676","catalogNumber":"4676","dunsNumber":"076769355","companyName":"HOBBS MEDICAL, INC.","deviceCount":25,"deviceDescription":"A device used to remove dirt or debris from the working channel(s) of the endoscope prior to disinfection and sterilization. It consists of a flexible insertion tube with plastic bristles. This is a single-use device.\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"8606845875","phoneExtension":null,"email":"customerservice@hobbsmedical.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K933354","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"38835","gmdnPTName":"Surgical instrument/endoscope cleaning utensil, single-use","gmdnPTDefinition":"A non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"FEB","productCodeName":"Accessories, Cleaning, For Endoscope"}]},"deviceSizes":{"deviceSize":[]},"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}