[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PHN":3},{"classification":4,"mappedDevices":39,"similarCandidates":40,"relatedClassifications":123,"syncDates":124,"translation":37,"marketSummary":37,"recalls":131,"k510s":133,"pmas":155},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":9,"medical_specialty_description":10,"review_panel":11,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":14,"raw":15,"created_at":34,"updated_at":35,"recall_count":36,"latest_recall_date":37,"k510_count":38,"pma_count":36,"event_count":36},6720,"PHN","Protective Coating, Mucoadhesive Application, For The Rectal Mucosa","U","","Unknown","GU","1","Mucoadhesive application for the protective coating of the rectal mucosa.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":9,"device_class":8,"implant_flag":32,"product_code":6,"review_panel":11,"gmp_exempt_flag":32,"third_party_flag":32,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":12,"life_sustain_support_flag":32,"medical_specialty_description":10,"summary_malfunction_reporting":33},{"k_number":17,"fei_number":23,"registration_number":30},[18,19,20,21,22],"K261504","K213552","K242634","K253923","K140558",[24,25,26,27,28,29],"3005689226","3016611551","3015528146","3005465238","3003870583","3012263097",[24,25,26,27,29,31],"3004681519","N","Eligible","2026-08-18T05:52:53.686257+00:00","2026-08-18T22:05:38.961415+00:00",0,null,5,[],[41,50,58,66,75,84,92,101,108,116],{"medical_device_id":42,"generic_name":43,"class_classification":44,"jmdn_code":45,"name_similarity":46,"definition_similarity":47,"vector_similarity":48,"score":49},2647,"歯科矯正用長期粘膜保護材","Ⅱ","70738000",0.222222,0.242424,0.684819,0.0310245,{"medical_device_id":51,"generic_name":52,"class_classification":44,"jmdn_code":53,"name_similarity":54,"definition_similarity":55,"vector_similarity":56,"score":57},2777,"歯科接着・充填材料用表面硬化保護材","70858000",0.277778,0.21875,0.650423,0.029907,{"medical_device_id":59,"generic_name":60,"class_classification":44,"jmdn_code":61,"name_similarity":62,"definition_similarity":63,"vector_similarity":64,"score":65},3208,"家庭用鼻腔粘膜保護材","60371002",0.205479,0.166667,0.713029,0.0294624,{"medical_device_id":67,"generic_name":68,"class_classification":69,"jmdn_code":70,"name_similarity":71,"definition_similarity":72,"vector_similarity":73,"score":74},4068,"短期的使用歯科矯正用粘膜保護材","Ⅰ","70735000",0.197674,0.210145,0.714566,0.0293805,{"medical_device_id":76,"generic_name":77,"class_classification":78,"jmdn_code":79,"name_similarity":80,"definition_similarity":81,"vector_similarity":82,"score":83},873,"直腸・肛門用アフターローディング式ブラキセラピー装置アプリケータ","Ⅲ","38431000",0.272727,0.137184,0.640144,0.0277569,{"medical_device_id":85,"generic_name":86,"class_classification":78,"jmdn_code":87,"name_similarity":88,"definition_similarity":89,"vector_similarity":90,"score":91},872,"直腸・肛門用手動式ブラキセラピー装置アプリケータ","38430000",0.2625,0.129139,0.6173,0.015873,{"medical_device_id":93,"generic_name":94,"class_classification":95,"jmdn_code":96,"name_similarity":97,"definition_similarity":98,"vector_similarity":99,"score":100},183,"癒着防止吸収性バリア","Ⅳ","34212000",0.146341,0.13245,0.678021,0.015625,{"medical_device_id":102,"generic_name":103,"class_classification":69,"jmdn_code":104,"name_similarity":105,"definition_similarity":106,"vector_similarity":107,"score":100},4002,"歯科用充填・修復材補助器具","38782000",0.259259,0.126984,0.569654,{"medical_device_id":109,"generic_name":110,"class_classification":78,"jmdn_code":111,"name_similarity":112,"definition_similarity":113,"vector_similarity":114,"score":115},416,"ヘパリン使用排液用チューブ","14191203",0.0617284,0.164384,0.674218,0.0153846,{"medical_device_id":117,"generic_name":118,"class_classification":78,"jmdn_code":119,"name_similarity":120,"definition_similarity":121,"vector_similarity":122,"score":115},869,"前立腺用アフターローディング式ブラキセラピー装置アプリケータ","38427000",0.244444,0.134058,0.555577,[],{"510k":125,"classification":126,"enforcement":127,"event":128,"pma":129,"warning_letter":130},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-20T03:28:02.95+00:00",{"items":132,"total":36},[],{"items":134,"total":38},[135,142,147,149,151],{"k_number":18,"device_name":136,"applicant":137,"decision_date":138,"clearance_type":139,"decision_code":140,"statement_or_summary":141},"PuraStat-RM","3-D Matrix, Inc.","2026-08-03","Traditional","SESE","Summary",{"k_number":21,"device_name":143,"applicant":144,"decision_date":145,"clearance_type":146,"decision_code":140,"statement_or_summary":141},"PuraStat","3-D Matrix Europe SAS","2026-01-07","Special",{"k_number":20,"device_name":143,"applicant":144,"decision_date":148,"clearance_type":139,"decision_code":140,"statement_or_summary":141},"2025-01-15",{"k_number":19,"device_name":136,"applicant":137,"decision_date":150,"clearance_type":139,"decision_code":140,"statement_or_summary":141},"2022-04-01",{"k_number":22,"device_name":152,"applicant":153,"decision_date":154,"clearance_type":139,"decision_code":140,"statement_or_summary":141},"PROCTIGARD","Access Pharmaceuticals, Inc.","2014-07-16",{"items":156,"total":36},[]]