{"publicDeviceRecordKey":"36f4d863-be03-4a80-88ab-817cdd37549d","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2026-04-13T00:00:00.000Z","devicePublishDate":"2018-09-28T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"10816848024019","deviceIdType":"Package","deviceIdIssuingAgency":"GS1","containsDINumber":"00816848024012","pkgQuantity":12,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"Box"},{"deviceId":"00816848024012","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"SUPRAMID EXTRA","versionModelNumber":"Code XHEA-40B-20","catalogNumber":"Code XHEA-40B-20W","dunsNumber":"069277028","companyName":"S JACKSON INC","deviceCount":1,"deviceDescription":"3/8 Circle Micro-Cutting Taper Point Needle (18.7mm), USP 4-0 SUPRAMID EXTRA black cable-type Nylon, 20\" Loop","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":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"8003685225","phoneExtension":null,"email":"sales@supramid.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"37997","gmdnPTName":"Nylon suture, non-bioabsorbable, multifilament, non-antimicrobial","gmdnPTDefinition":"A multiple-strand (multifilament), synthetic, non-bioabsorbable thread made of nylon (a polyamide polymer) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"GAR","productCodeName":"Suture, Nonabsorbable, Synthetic, Polyamide"}]},"deviceSizes":{"deviceSize":[]},"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":[]}}