{"publicDeviceRecordKey":"cc076ce9-f8f2-4cf3-ae27-9a8754211797","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2025-05-02T00:00:00.000Z","devicePublishDate":"2016-09-16T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"20818392010569","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"10818392010562","pkgQuantity":8,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Case"},{"deviceId":"10818392010562","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00818392010565","pkgQuantity":100,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Box"},{"deviceId":"00818392010565","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"SOL-CARE™ Safety Needle","versionModelNumber":"SN2158","catalogNumber":null,"dunsNumber":"069590113","companyName":"Sol-Millennium Medical, Inc.","deviceCount":1,"deviceDescription":"The SOL-CARE™ Safety Needle is used for general purpose injection and aspiration of fluids from vials, ampules, and parts of the body below the surface of the skin. 21g x 5/8\" safety needle","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":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"8336370857","phoneExtension":null,"email":"info@solm.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"17812","gmdnPTName":"Needle guard","gmdnPTDefinition":"A cap/cover intended to be extended over a used needle (attached to a syringe/autoinjector or not) to prevent accidental needle sticks, typically during removal of the needle. It is typically a plastic housing with appropriate shielding to prevent injury upon application, and is typically disposed of with the needle; it is not the needle cap provided with the needle. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"},{"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":"Needle Gauge","size":{"unit":"Gauge","value":"21"},"sizeText":null,"sizeString":"Needle Gauge: 21 Gauge"},{"sizeType":"Length","size":{"unit":"Millimeter","value":"16"},"sizeText":null,"sizeString":"Length: 16 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,"premarketSubmissions":{"premarketSubmission":[]}}