{"publicDeviceRecordKey":"ddc746f1-7a0a-476a-bc42-c4fea6a5dc0f","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2026-05-07T00:00:00.000Z","devicePublishDate":"2026-04-29T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08800042700829","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Artisential Monopolar Spatula","versionModelNumber":"AMT01L-L","catalogNumber":null,"dunsNumber":"688360116","companyName":"LIVSMED","deviceCount":1,"deviceDescription":"This device is a sterile, single-use instrument intended to be used with an electrosurgical generator to deliver electrosurgical current in a monopolar configuration for tissue incision and coagulation.","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":"MR Unsafe","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"833-548-7633","phoneExtension":null,"email":"infousa@livsmed.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K230498","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"61875","gmdnPTName":"Endoscopic electrosurgical electrode, monopolar, single-use","gmdnPTDefinition":"A sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GEI","productCodeName":"Electrosurgical, Cutting \u0026 Coagulation \u0026 Accessories"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"8"},"sizeText":null,"sizeString":"Outer Diameter: 8 Millimeter"},{"sizeType":"Shaft Length","size":{"unit":"Millimeter","value":"450"},"sizeText":null,"sizeString":"Shaft Length: 450 Millimeter"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Humidity","storageHandlingHigh":{"unit":"Percent (%) Relative Humidity","value":"80"},"storageHandlingLow":{"unit":"Percent (%) Relative Humidity","value":""},"storageHandlingSpecialConditionText":null},{"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}