{"publicDeviceRecordKey":"f4d8d429-c248-43d5-83a9-eb96996bbfb2","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2025-10-29T00:00:00.000Z","devicePublishDate":"2016-06-01T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00887482104149","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Symmetry Surgical Rhoton®","versionModelNumber":"58-6347","catalogNumber":"58-6347","dunsNumber":"027680821","companyName":"ASPEN SURGICAL PRODUCTS, INC.","deviceCount":1,"deviceDescription":"Rhoton Suction Tube; Atraumatic; Curved Down; 7 Fr; 5 1/8 in (130 mm) Working Length","DMExempt":true,"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":"+1 888-364-7004","phoneExtension":null,"email":"customerservice@symmetrysurgical.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"38749","gmdnPTName":"Surgical/emergency suction cannula, non-illuminating, reusable","gmdnPTDefinition":"An atraumatic, invasive, hand-operated, single-lumen, rigid/semi-rigid tube designed as a conduit for aspiration of body cavities, wounds, or surgical sites to facilitate observation and/or to clear an airway obstruction. It is not dedicated to dental, intrauterine, or liposuction procedures, and is neither an ophthalmic nor an intravascular device; it is not designed for surgical irrigation. Sometimes referred to as a suction tube or tip, it may incorporate a handle with side valve(s)/hole(s), and may be provided with a stylet, sheath, and/or connection tubing; it does not include a light source or fibreoptic bundle. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"JOL","productCodeName":"Catheter And Tip, Suction"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Inch","value":"5.125"},"sizeText":null,"sizeString":"Length: 5.125 Inch"},{"sizeType":"Catheter Gauge","size":{"unit":"French","value":"7"},"sizeText":null,"sizeString":"Catheter Gauge: 7 French"}]},"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":[]}}