PROVIDE PROTECTION CAP KITS

  • Modelo / Serial
    Model Number: PAK4140, Lot Numbers: 977597, 981669, 984020, 987879, 989549, 995908, 1001595, 1004140, 1008710, 1010960, 1014334, 1015290, 1040122, 1040123, 1041414, 1045559, 1051854, 1052717, 1057786, 1062286, 1062287, 1062316, 1062317, 1065506, 1069146, 1069147, 1069996, 1075432, 1077541, 1077695, 1079484, 1087552, 1092512, 1095127, 1101673, 1108857, 1116020, 1124781, 1126602, 1133466, 1138040, 1142164, 1142165, 1142166,1142167, 1146388, 1146389, 1146390, 1154210, 1155762, 1161343, 1165414, 1166599, 1169299, 1170515, 1171394,1172306,1172307,1173594,1177247, 1177864, 1180531, 1180696, 1182190, 1182794, 1184132, 1184574, 1184575;   Model Number: PAK4155, Lot Numbers: 1093011, 1109345, 1124776, 1130228, 1147152, 1165412, 1173301, 1179689, 1179946, 1181748, 1182412, 1183051, 1183632;  Model Number: PAK4240, Lot Numbers: 976863, 984016, 989553, 1002872, 1008694, 1014133, 1040125, 1040126, 1053095, 1053272, 1054998, 1057787, 1059216, 1062288, 1062289, 1062315, 1063247, 1065954, 1069997, 1075433, 1077542, 1078854, 1100721, 108854, 1115057, 1118381, 1130245, 1133478,1142170, 1142171, 1145306, 1145307, 147153, 1154213, 1161339, 1165350, 1166597, 1166982, 171069, 1171551, 1172742, 1173592, 1174352, 1175517, 1177865, 1179604, 1183052, 1184133, 1184577, 1184578;  Model Number: PAK4255, Lot Numbers: 1101674, 1101932, 1145936, 1165798, 1172302, 1182694;  Model Number: PAK4340, Lot Numbers: 984895, 996687, 1040764, 1054537, 1062290, 1063244, 1063585, 1071105, 1076277, 1139560, 145302,1150519, 1166596,1174356, 1184854;  Model Number: PAK4355, Lot Numbers: 1076102, 1095125, 1124758, 1178454;  Model Number: PAK4440, Lot Numbers: 990071, 1040763, 1062307, 1062314, 1165408, 1173300, 1175589;  Model Number: PAK4455, Lot Numbers: 1143174, 1166992;   Model Number: PAK5140, Lot Numbers: 987881, 992597, 993051, 1008713, 1016816, 1027348, 1030633, 1040152, 1053291, 1053292, 1055001, 1057776, 1059419, 1060681, 1060683, 1064187, 1068777, 1074334, 1075711, 1077697, 1090897, 1095824, 1109271, 1111471, 1119708, 1130992, 1133468, 1137566, 1147648, 1161335, 1165351, 1166598, 1170516, 1173302, 1175590, 1177233, 1178497, 1180268, 1182894, 1184581, 1186589;   Model Number: PAK5155, Lot Numbers: 1041413, 1057788, 1063243, 1070055, 1071759, 1104117, 1148540, 1173305, 1185657; Model Number: PAK5240, Lot Numbers: 980399, 985506, 996408, 1007895, 1014099, 1016185, 1028721, 1040149, 1041536, 1059511, 1060043, 1060680, 1062313, 1064628, 1069149, 1074333, 1075709, 1077543, 1088474, 1088476, 1109337, 1113209, 1134520, 1148634, 1161340, 1166594, 1170178, 1172113, 1173461, 1174931, 1180198, 1180199, 1182651, 1183054, 1184580;  Model Number: PAK5255, Lot Numbers: 1042331, 1057791, 1063087, 1071336, 1090926, 1099823, 1131855, 1170697, 1185655;  Model Number: PAK5340, Lot Numbers: 989548, 1007893, 1030631, 1048667, 1054937, 1063528, 1068338, 1075434, 1116022, 1166993;  Model Number: PAK5355, Lot Numbers: 1100717, 1170177, 1176295, 1184856;   Model Number: PAK5440, Lot Numbers: 1007892, 1062309, 1069150, 1115058,1165410, 1177485;  Model Number: PAK5455, Lot Numbers: 1090053, 1174219;  Model Number: PAK6140, Lot Numbers: 984892, 1007891, 1040155, 1057789, 1063085, 1090930, 1109781, 1154439, 1174355;   Model Number: PAK6155, Lot Numbers: 1060679, 1096852, 1148501, 1165347;  Model Number: PAK6240, Lot Numbers: 996407, 1040156, 1051074, 1057792, 1070221, 1076288, 1138038, 1176971;  Model Number: PAK6255, Lot Numbers: 1063084, 1178839;  Model Number: PAK6340, Lot Numbers: 984894, 1057794, 1090929, 1116021;  Model Number: PAK6355, Lot Number: 1062806;  Model Number: PAK6440, Lot Number: 993055;  Model Number: PAK6455, Lot Number: 1116019.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution: US (nationwide) and countries of: Canada, Argentina, Austria, Australia, Brazil, Chile, China, Colombia, Costa Rica, Germany, Dominican Republic, Spain, France, Great Britain, Hong Kong, Ireland, Israel, India, Korea, Kuwait, Lithuania, Mexico, Netherlands, Portugal, Saudi Arabia, Sweden, Singapore, Taiwan, Venezuela, and South Africa.
  • Descripción del producto
    BIOMET 3i, PROVIDE PROTECTION CAP KITS, Catalog # PAK4140, PAK4155, PAK4240, PAK4255, PAK4340, PAK4355, PAK4440, PAK4455, PAK5140, PAK5155, PAK5240, PAK5255, PAK5340, PAK5355, PAK5440, PAK5455, PAK6140, PAK6155, PAK6240, PAK6255, PAK6340, PAK6355, PAK6440, and PAK6455 || BIOMET 3i Restorative Products are intended for use as an accessory to endosseous dental implants for placement in the maxilla and mandible. Provisional Abutments are intended for use as an accessory to endosseous dental implants to support a prosthetic device in a partially or fully edentulous patient. They are intended for use to support a prosthesis in the mandible or maxilla for up to 180 days during endosseous and gingival healing, and are for non-occlusal loading of provisional restorations.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Biomet 3i, LLC, 4555 Riverside Dr, Palm Beach Gardens FL 33410-4200
  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
  • Source
    USFDA