{"publicDeviceRecordKey":"65ad3a88-2c9a-498f-91b9-98cc2610d9bd","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2021-10-14T00:00:00.000Z","devicePublishDate":"2020-12-29T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08800023301403","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"08800023301397","pkgQuantity":100,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Small inner box"},{"deviceId":"08800023301397","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"08800023301410","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"08800023301403","pkgQuantity":10,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Middle inner box"},{"deviceId":"08800023301427","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"08800023301410","pkgQuantity":10,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Carton box"}]},"brandName":"Dana Acupuncture needle Pouch 10T","versionModelNumber":"ANS18-3020","catalogNumber":null,"dunsNumber":"689851191","companyName":"DANA medical.co.ltd","deviceCount":1,"deviceDescription":"Dana Acupuncture Needles are high quality bulk packaged needles in Pouches. Dana Acupuncture Needles are manufactured by Dana Medical Co., Ltd. with the most advanced automatic manufacturing facility of Acupuncture needles in Korea with Excellent needle tip polishing technology allowing you smooth insertion feeling of needles into patient's body. Dana Acupuncture Needle Pouch 10T contains 10 needles with 1 guide tube per sterile pouch packages in a Box of 1,000 needles. ","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":true,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"+82613949288","phoneExtension":null,"email":"okdana1@hanmail.net"}]},"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":[]},"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":[]}}