{"publicDeviceRecordKey":"c616b495-dd5f-45cd-aa8b-9de3d2b09654","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2025-12-29T00:00:00.000Z","devicePublishDate":"2017-12-22T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B491DB18407","deviceIdType":"Package","deviceIdIssuingAgency":"HIBCC","containsDINumber":"B491DB18405","pkgQuantity":10,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":null},{"deviceId":"B491DB18405","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"B491DB18400","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"KSC DB PLUS","versionModelNumber":"DB-1840","catalogNumber":"DB-1840","dunsNumber":"654613546","companyName":"Wujiang City ShenLing Medical Device Co.,Ltd","deviceCount":1000,"deviceDescription":"Smooth and sharp for painless, DB Plus disposable sterile acupuncture needles are made of high quality surgical stainless steel and the handle is without loop. Sterilized with Ethylene Oxide. This is a bulk pack offering a more economical price. 10 needles with one (insertion) guide tube per sterile, individually sealed blister package. Box of 1000 needles. 0.18mm x 40mm (38# x 1.5\").\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":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K002411","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"34175","gmdnPTName":"Acupuncture needle, single-use","gmdnPTDefinition":"A sterile, long, slender, sharply-pointed instrument used to stimulate peripheral nerves in order to produce surgical anaesthesia, relieve pain, and to promote other therapeutic effects. It is widely used in complementary therapy. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"MQX","productCodeName":"Needle, Acupuncture, Single Use"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Needle Size 0.18mm x 40mm "}]},"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}