XcelGel
PC1097M McGuire Frame and Sacral and Hip Pd 10-1/2" x 17" x 3/8" and 10-1/2" x 11" x 3/8"
4manufacturers in China registered for this device type
211catalogue numbers in this listing
Who Else Makes It
Concentrated in Hebei (3), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Shijiazhuang Aofeite Medical Device Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 28 |
| Hebei Webian Medical Instrument Trading Co., Ltd. | Shijiazhuang | Hebei | Manufacturer | 14 |
| HI-Life Technology (Hebei) Co., Ltd. | Bazhou | Hebei | Manufacturer | 11 |
Record
| Listed by | Polymer Concepts, Inc., United States |
|---|---|
| FDA product code | LWG |
| Device type | Surgical Table Cushion |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4950 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-04-28 |
| Record revised | 2022-09-09 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Latex | Contains natural rubber latex |
| Distribution end date | 2022-09-08 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PC1013 | In distribution | |
| PC1045L | In distribution | |
| PC1035 | In distribution | |
| PC1150 | In distribution | |
| PC1112 | In distribution | |
| PC1002 | In distribution | |
| PC1005-B | In distribution | |
| PC1031 | In distribution | |
| PC1010 SET | In distribution | |
| PC1039 | In distribution | |
| PC1121 | In distribution | |
| PC1120 | In distribution | |
| PC0422 | In distribution | |
| PC1135 | In distribution | |
| PC1075 | In distribution | |
| PC1069 | In distribution | |
| PC1011 SET | In distribution | |
| PC1061 | In distribution | |
| PC1072 | In distribution | |
| PC0448 | In distribution | |
| PC1137 | In distribution | |
| PC1027 | In distribution | |
| PC-ARC | In distribution | |
| PC1020 | In distribution | |
| PC1125 | In distribution | |
| PC1157 | In distribution | |
| PC1091 | In distribution | |
| PC1095 | In distribution | |
| PC1143 | In distribution | |
| PC1054 | In distribution | |
| PC1006 | In distribution | |
| PC1078 | In distribution | |
| PC1119 | In distribution | |
| PC1055 | In distribution | |
| PC1146 | In distribution | |
| PC1045R | In distribution | |
| PC1612 | In distribution | |
| PC1040 SET | In distribution | |
| PC1108 | In distribution | |
| PC1097L | In distribution | |
| PC2207SD | In distribution | |
| PC1049 | In distribution | |
| PC1139 | In distribution | |
| PC1043 | In distribution | |
| PC-CRC | In distribution | |
| PC1018 | In distribution | |
| PC0633 | In distribution | |
| PC1033 | In distribution | |
| PC1127 | In distribution | |
| PC0822 | In distribution | |
| PC1111 | In distribution | |
| PC1058 | In distribution | |
| PC1050 | In distribution | |
| PC1064 | In distribution | |
| PC1077 | In distribution | |
| PC1060 | In distribution | |
| PC1154A | In distribution | |
| PCMINI | In distribution | |
| PC1029 | In distribution | |
| FLATP1616 | In distribution | |
| PC1012 | In distribution | |
| PC1041 | In distribution | |
| PC1023 | In distribution | |
| PC0022 | In distribution | |
| PC1016-4C | In distribution | |
| PC1059 | In distribution | |
| PC1136 | In distribution | |
| PC1025 | In distribution | |
| PC1107 | In distribution | |
| PC2115 | In distribution | |
| PC3804 | In distribution | |
| PC1016 | In distribution | |
| PC1094 | In distribution | |
| PC1067 | In distribution | |
| PC1222 | In distribution | |
| PC1158 | In distribution | |
| APH2IN | In distribution | |
| PC2000 | In distribution | |
| PC1071 | In distribution | |
| PC1024 | In distribution | |
| PC1106 | In distribution | |
| PC1034 | In distribution | |
| PC1117 | In distribution | |
| PC2055 | In distribution | |
| FLATP1816 | In distribution | |
| PC1088 | In distribution | |
| PC1003 | In distribution | |
| PC1103 | In distribution | |
| PC1020-24 | In distribution | |
| PC1102 | In distribution | |
| PC1138 | In distribution | |
| PC1040SD | In distribution | |
| PC1022 | In distribution | |
| PC1038 | In distribution | |
| PC1100 | In distribution | |
| PC0833 | In distribution | |
| PC1079 | In distribution | |
| PC1154C | In distribution | |
| PC1151 SET | In distribution | |
| PC1045 SET | In distribution | |
| PC1133 | In distribution | |
| APH3IN | In distribution | |
| PC1005 | In distribution | |
| PC1082 SET | In distribution | |
| PC2424 | In distribution | |
| PC1115 | In distribution | |
| PC0433 | In distribution | |
| PC1070 | In distribution | |
| PC1109 | In distribution | |
| PC1096 | In distribution | |
| PC1093 | In distribution | |
| PC1154 | In distribution | |
| PC1803 | In distribution | |
| PC1021 | In distribution | |
| PC1046 | In distribution | |
| PC1001 | In distribution | |
| PC5120 | In distribution | |
| PC1027 SET | In distribution | |
| PC1110 | In distribution | |
| PC1018-4C | In distribution | |
| PC1159 | In distribution | |
| PC1048 | In distribution | |
| PC1124 | In distribution | |
| PC1042 | In distribution | |
| PC1037 | In distribution | |
| PC1051 | In distribution | |
| FLATP2020 | In distribution | |
| PC1015 | In distribution | |
| PC1145 | In distribution | |
| PC1114 | In distribution | |
| PC2207 SET | In distribution | |
| APH1IN | In distribution | |
| PC1036 | In distribution | |
| PC1014 | In distribution | |
| PC1087 | In distribution | |
| PC1017 | In distribution | |
| PC1118 | In distribution | |
| PC1147GP | In distribution | |
| PC1212 | In distribution | |
| PC1089 | In distribution | |
| PC1099 | In distribution | |
| PC1105 | In distribution | |
| PC1074 | In distribution | |
| PC1152 | In distribution | |
| PC0033 | In distribution | |
| PC1165 | In distribution | |
| PC1040GP | In distribution | |
| PC1233 | In distribution | |
| PC1009 | In distribution | |
| PC1086 | In distribution | |
| PC1149 | In distribution | |
| PC1085 SET | In distribution | |
| PC1062 | In distribution | |
| PC1083 SET | In distribution | |
| PC2225 | In distribution | |
| PC1153 | In distribution | |
| PC1066 | In distribution | |
| PC1098 | In distribution | |
| PC1092 | In distribution | |
| PC1116 | In distribution | |
| PC1076 | In distribution | |
| PC1052 | In distribution | |
| PC1073 | In distribution | |
| PC1015-24 | In distribution | |
| PC1047 | In distribution | |
| PC1053 | In distribution | |
| PC1148 | In distribution | |
| PC1057 | In distribution | |
| PC1131 | In distribution | |
| PC1008 | In distribution | |
| PC1028 | In distribution | |
| PC1130 | In distribution | |
| PC1068 | In distribution | |
| PC1056 | In distribution | |
| FLATP1818 | In distribution | |
| PC1029-0 | In distribution | |
| PC1090 | In distribution | |
| PC1113 | In distribution | |
| PC1016-B | In distribution | |
| PC1156 | In distribution | |
| PC1126 | In distribution | |
| PC1084 | In distribution | |
| PC1026 | In distribution | |
| PC1000 | In distribution | |
| PC3618 | In distribution | |
| PC1081 | In distribution | |
| PC1154B | In distribution | |
| PC1043 SET | In distribution | |
| PC1132 | In distribution | |
| PC1104 | In distribution | |
| PC0622 | In distribution | |
| PC1128 | In distribution | |
| PC1080 | In distribution | |
| PC1044 | In distribution | |
| P:C1097M | In distribution | |
| PC2207GP | In distribution | |
| PC1007 | In distribution | |
| PC1134 | In distribution | |
| PC-RPK | In distribution | |
| PC1030 | In distribution | |
| PC1160 | In distribution | |
| PC7027 | In distribution | |
| PC1032 | In distribution | |
| PC1063 | In distribution | |
| PC1129 | In distribution | |
| PC7710 | In distribution | |
| PC1004 | In distribution | |
| PC1019 | In distribution | |
| PC1123 | In distribution | |
| PC7710 SET | In distribution | |
| PC1036 TALL | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Birkova | Steris Corporation | 455 |
| Rayshield | Aadco Medical, Inc. | 381 |
| Coulmed | Coulmed Products Group LLC | 343 |
| Skytron | Skytron, LLC | 307 |
| Aadco | Aadco Medical, Inc. | 267 |
| Surgical Table Cushion | Steris Corporation | 265 |
| Tablepad | Burlington Medical, LLC | 145 |
| Surgical Table Cushion | David Scott Company. | 107 |
| Prime Medical LLC | Prime Medical, Inc. | 81 |
| C-Matt | Casco Manufacturing Solutions, Inc. | 68 |
| Operon | Stryker Communications, Inc. | 31 |
| Medline | Medline Industries, Inc. | 24 |
Showing 12 of 369. All products under Surgical Table Cushion
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.