{"publicDeviceRecordKey":"ed9d0bbf-aca4-4bf4-bff2-2ac18ba3e75a","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2019-10-23T00:00:00.000Z","devicePublishDate":"2019-02-23T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"18809445831793","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"08809445831796","pkgQuantity":12,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"case"},{"deviceId":"08809445831796","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"28809445831790","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"18809445831793","pkgQuantity":6,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Master case"}]},"brandName":"TopFine®","versionModelNumber":"TopFine®Insulin Pen Needles 31Gx10mm 100pcs","catalogNumber":null,"dunsNumber":"689719789","companyName":"MEDEXEL CO.,LTD.","deviceCount":1,"deviceDescription":"Top Fine® Pen Needles are single use, sterile, medical devices designed to be used in conjunction with pen injectors and pen cartridges. Pen needles are used by consumers, caregivers and health care professionals. They are offered in various gauge sizes (29G, 30G, 31G, 32G, 33G and 34G) and lengths (4mm, 5mm, 6mm, 8mm, 12mm, and 12.7mm). Top Fine® Pen Needles are sterile (EO gas sterilization), non-toxic and non-pyrogenic.\nTop Fine® Pen Needle assembly consists of hub, needle, needle cap, sterile cap and sterile paper.\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+821044040469","phoneExtension":null,"email":"parkhj@medexel.co.kr"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K152410","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"59230","gmdnPTName":"Hypodermic needle, single-use","gmdnPTDefinition":"A non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"FMI","productCodeName":"Needle, Hypodermic, Single Lumen"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Millimeter","value":"10"},"sizeText":null,"sizeString":"Length: 10 Millimeter"},{"sizeType":"Needle Gauge","size":{"unit":"Gauge","value":"31"},"sizeText":null,"sizeString":"Needle Gauge: 31 Gauge"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"30"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"1"},"storageHandlingSpecialConditionText":null}]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}