[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PUC":3},{"classification":4,"mappedDevices":55,"similarCandidates":56,"relatedClassifications":135,"syncDates":140},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":10,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":14,"raw":15,"created_at":52,"updated_at":52,"recall_count":53,"latest_recall_date":54,"k510_count":53,"pma_count":53,"event_count":53},5446,"PUC","Microtools, Assisted Reproduction (Pipettes), Exempt","2","884.6130","OB","Obstetrics\u002FGynecology","4","This product code is the class II exempt counterpart of MQH, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the “Physical State” field of this product code description.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":49,"device_class":8,"implant_flag":50,"product_code":6,"review_panel":10,"gmp_exempt_flag":50,"third_party_flag":50,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":49,"life_sustain_support_flag":50,"medical_specialty_description":11,"summary_malfunction_reporting":51},{"fei_number":17,"registration_number":46},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45],"3006405073","3014882136","3016214552","3013894805","3016126174","3033740404","1216677","2245304","3002757762","1221433","3003995932","3014295858","3023235140","3008559295","3030541196","3015739059","3003744503","3015140190","1220477","3042228693","1000136478","3015529470","3006017180","3006617533","3040387472","3010187826","2522007","3008876063",[18,47,19,20,21,22,23,24,25,48,27,28,29,30,31,32,33,34,35,36,37,39,40,41,42,43,44,45],"2031824","1319660","","N","Ineligible","2026-08-18T05:52:52.566809+00:00",0,null,[],[57,66,74,83,90,98,105,112,120,127],{"medical_device_id":58,"generic_name":59,"class_classification":60,"jmdn_code":61,"name_similarity":62,"definition_similarity":63,"vector_similarity":64,"score":65},3584,"回転式ミクロトーム","Ⅰ","15158000",0.140351,0.140673,0.630447,0.0292869,{"medical_device_id":67,"generic_name":68,"class_classification":60,"jmdn_code":69,"name_similarity":70,"definition_similarity":71,"vector_similarity":72,"score":73},3586,"再使用可能なミクロトーム用刃","42439000",0.138462,0.126844,0.592228,0.0244484,{"medical_device_id":75,"generic_name":76,"class_classification":77,"jmdn_code":78,"name_similarity":79,"definition_similarity":80,"vector_similarity":81,"score":82},2404,"再使用可能な間欠的強制換気補助人工呼吸器呼吸回路","Ⅱ","42909000",0.020202,0.193989,0.643019,0.0163934,{"medical_device_id":84,"generic_name":85,"class_classification":60,"jmdn_code":86,"name_similarity":87,"definition_similarity":88,"vector_similarity":89,"score":82},3305,"放射線防護用ミトン","38365000",0.174603,0.203747,0.505195,{"medical_device_id":91,"generic_name":92,"class_classification":77,"jmdn_code":93,"name_similarity":94,"definition_similarity":95,"vector_similarity":96,"score":97},2922,"針付バイブレータ","70979000",0.178571,0.131833,0.546132,0.016129,{"medical_device_id":99,"generic_name":100,"class_classification":77,"jmdn_code":101,"name_similarity":53,"definition_similarity":102,"vector_similarity":103,"score":104},2403,"間欠強制換気補助人工呼吸器呼吸回路","16803000",0.158192,0.626313,0.015873,{"medical_device_id":106,"generic_name":107,"class_classification":60,"jmdn_code":108,"name_similarity":109,"definition_similarity":110,"vector_similarity":111,"score":104},4451,"非能動型展伸・屈伸運動訓練補助器具","71094001",0.152941,0.214765,0.486537,{"medical_device_id":113,"generic_name":114,"class_classification":115,"jmdn_code":116,"name_similarity":79,"definition_similarity":117,"vector_similarity":118,"score":119},826,"連続ポータブル腹膜灌流用運搬セット","Ⅲ","35986000",0.123839,0.625694,0.015625,{"medical_device_id":121,"generic_name":122,"class_classification":77,"jmdn_code":123,"name_similarity":124,"definition_similarity":125,"vector_similarity":126,"score":119},2521,"能動型手用他動運動訓練装置","17137002",0.166667,0.122977,0.436043,{"medical_device_id":128,"generic_name":129,"class_classification":77,"jmdn_code":130,"name_similarity":131,"definition_similarity":132,"vector_similarity":133,"score":134},2984,"避妊用ミクロコンドーム","34030000",0.0735294,0.113014,0.617935,0.0153846,[136],{"product_code":137,"device_name":138,"device_class":8,"k510_count":139},"MQH","Microtools, Assisted Reproduction (Pipettes)",26,{"510k":141,"classification":142,"enforcement":143,"event":144,"pma":145,"warning_letter":146},"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","2026-08-18T06:42:29.411+00:00"]