{"publicDeviceRecordKey":"7f5ede65-8b4b-4013-8af1-210fd2cdadd3","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2023-06-30T00:00:00.000Z","devicePublishDate":"2023-06-22T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00842180171237","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"ELMED","versionModelNumber":"18-14-27-I","catalogNumber":"18-14-27-I","dunsNumber":"049290364","companyName":"ELMED INCORPORATED","deviceCount":1,"deviceDescription":"STANDARD ANDREWS-PYNCHON SUCTION TUBE,1/2\" DIAMETER TIP, 9 1/2' OVERALL LENGTH. AUTOCLAVABLE MEDICAL GRADE STAINLESS STEEL, Insulated Shaft(Blue), exposed tip and handle \n","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"224-353-6446","phoneExtension":null,"email":"medical@elmed.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"64119","gmdnPTName":"Surgical irrigation/aspiration cannula, non-illuminating, reusable","gmdnPTDefinition":"An atraumatic, invasive, hand-operated tube designed as a conduit for irrigation and aspiration (i.e., capable of both functions) of body cavities/wounds during a surgical procedure (e.g., neurosurgery, laparoscopy), typically to facilitate observation. It is not dedicated to dental or intrauterine procedures, not an ophthalmic device, and is not designed to administer parenteral fluids or drugs. It might incorporate a handle with a valve(s) and hole(s) on its side for the control of irrigation/aspiration, and may be provided with a stylet, a sheath, and/or connection tubing; it is typically made of metal. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GEN","productCodeName":"Forceps, General \u0026 Plastic Surgery"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Moist Heat or Steam Sterilization"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}