{"publicDeviceRecordKey":"26a08e58-bac1-4290-9f7d-402fb9b4fa5d","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2024-04-17T00:00:00.000Z","devicePublishDate":"2022-11-30T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"B382SD74CL690","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Surgical Direct","versionModelNumber":"SD74CL69","catalogNumber":"SD74CL69","dunsNumber":"124367223","companyName":"Surgical Direct, Inc.","deviceCount":1,"deviceDescription":"Large Clips, 1 Box of 20 Cartridges, 6 Clips per Cartridge, Weck Compatible","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"+1 (800) 519-3293","phoneExtension":null,"email":"info@surgicaldirect.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K974382","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"35798","gmdnPTName":"Open-surgery ligation clip applier","gmdnPTDefinition":"A hand-held manual surgical instrument designed to apply small atraumatic clips (not included) for the ligation of blood vessels, or similar tubular anatomy, mainly to prevent and/or stop bleeding (i.e., haemostasis) during an open-surgery procedure. It may also be used to apply small clamps (e.g., bulldog type) to tissues however it is not intended to apply an aneurysm clip. The device is typically a metallic instrument with flat, curved ends to hold and deliver the clips (e.g., forceps-like); implantable clips are not included. This is a reusable device after sterilization.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GCJ","productCodeName":"Laparoscope, 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}