{"publicDeviceRecordKey":"0bd30024-0e55-464e-bb4e-b03cdea9f344","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2026-02-09T00:00:00.000Z","devicePublishDate":"2026-01-30T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"09421908222416","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Myriad Matrix™ Restore Restorative Bioscaffold","versionModelNumber":"SR02LG006R","catalogNumber":null,"dunsNumber":"594540572","companyName":"AROA BIOSURGERY LIMITED","deviceCount":1,"deviceDescription":"Myriad Matrix Restore is an intact extracellular matrix (ECM) derived from ovine (sheep) forestomach tissue. This advanced ECM scaffold is non-reconstituted collagen, thus it retains the innate biological structure and function of the native ECM associated macromolecules including elastin, fibronectin, glycosaminoglycans and laminin.","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"MR Safe","rx":true,"otc":false,"contacts":{"customerContact":[]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K162461","supplementNumber":"000"},{"submissionNumber":"K171231","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"60907","gmdnPTName":"Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial","gmdnPTDefinition":"A bioabsorbable, implantable material (e.g., flat sheet) made from animal-derived collagen intended for extra-gynaecological, non-dental tissue repair/reinforcement application(s) [e.g., pericardial reinforcement, plastic surgery, abdominal hernia repair]; some types may also be intended for use as a short-term scaffold for tissue regeneration. It is constructed of collagen, which might be cross-linked (e.g., with glutaraldehyde); it does not include antimicrobial agents/materials. Disposable devices associated with implantation may be supplied with the mesh.","implantable":true,"gmdnCodeStatus":"Active"},{"gmdnCode":"45023","gmdnPTName":"Animal-derived wound matrix dressing","gmdnPTDefinition":"A bioabsorbable animal-derived protein matrix [e.g., peptides derived from collagen] designed to provide: 1) a matrix of structural proteins and/or 2) a skin template of living cells [fibroblasts], to facilitate the infiltration/attachment of native cells/tissues (e.g., blood vessels) for wound/skin healing. It is available in various forms [e.g., solution, powder, occlusive/semi-occlusive cover (non-oral)] and may include additional compounds (e.g., alginate, fatty acids). It may be intended to be covered with a secondary dressing. It is commonly intended for treating partial- and full-thickness wounds, ulcers, and draining, surgical, and traumatic wounds. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KGN","productCodeName":"Wound dressing with animal-derived material(s)"},{"productCode":"FTM","productCodeName":"Mesh, surgical"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"2 x 3 cm, 2 Layer"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Myriad Matrix Restore should be stored at room temperature in a clean and dry area."}]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}