Sklar®
Wire Spec Temp APP Nasal SD 2 Inches
9manufacturers in China registered for this device type
180catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (3), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| Zumax Medical Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Little Doctor Electronic(Nantong) Co., Ltd. | Nantong | Jiangsu | Contract manufacturer | 17 |
| Taizhou Honod Medical Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 7 |
| Yuyao Guangjing Medical Instrument Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
Record
| Listed by | Sklar Corporation, United States |
|---|---|
| FDA product code | EPY |
| Device type | Speculum, Ent |
| Device class | Class 1 |
| Regulation | 21 CFR 878.1800 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-04-10 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 67-6087 | In distribution | ||
| 67-6075 | In distribution | ||
| 70-1087 | In distribution | ||
| 67-6127 | In distribution | ||
| 96-2239M | 25 | In distribution | |
| 70-1064 | In distribution | ||
| 98-253 | 3 | In distribution | |
| 70-1016 | In distribution | ||
| 79-1002 | In distribution | ||
| 41-1196 | In distribution | ||
| 21-267 | 12 | In distribution | |
| 70-9241 | In distribution | ||
| 98-268 | In distribution | ||
| 67-6167 | In distribution | ||
| 67-6064 | In distribution | ||
| 67-6072 | In distribution | ||
| 67-6033 | In distribution | ||
| 67-6128 | In distribution | ||
| 67-6027 | In distribution | ||
| 67-6084 | In distribution | ||
| 70-1072 | In distribution | ||
| 67-6004 | In distribution | ||
| 67-6129 | In distribution | ||
| 67-6123 | In distribution | ||
| 67-6120 | In distribution | ||
| 67-6169 | In distribution | ||
| 67-6031 | In distribution | ||
| 70-1083 | In distribution | ||
| 67-6200 | In distribution | ||
| 70-1067 | In distribution | ||
| 70-1015 | In distribution | ||
| 67-6073 | In distribution | ||
| 67-6125 | In distribution | ||
| 70-1040 | In distribution | ||
| 67-6091 | In distribution | ||
| 22-8828 | In distribution | ||
| 67-6206 | In distribution | ||
| 67-6056 | In distribution | ||
| 79-1012 | In distribution | ||
| 67-6017 | In distribution | ||
| 70-1096 | In distribution | ||
| 67-6143 | 6 | In distribution | |
| 70-1084 | In distribution | ||
| 67-6012 | In distribution | ||
| 41-1194 | In distribution | ||
| 41-1193 | In distribution | ||
| 41-1200 | In distribution | ||
| 41-1198 | In distribution | ||
| 67-6049 | In distribution | ||
| 67-6043 | In distribution | ||
| 67-6093 | In distribution | ||
| 70-9243 | In distribution | ||
| 67-6115 | In distribution | ||
| 67-6047 | In distribution | ||
| 98-267 | In distribution | ||
| 67-6063 | In distribution | ||
| 70-9234 | In distribution | ||
| 79-1007 | In distribution | ||
| 70-1052 | In distribution | ||
| 70-9233 | In distribution | ||
| 70-9199 | In distribution | ||
| 67-6168 | In distribution | ||
| 67-6112 | In distribution | ||
| 67-6026 | In distribution | ||
| 70-9235 | In distribution | ||
| 67-6110 | In distribution | ||
| 67-6032 | In distribution | ||
| 67-6067 | In distribution | ||
| 70-1085 | In distribution | ||
| 67-6018 | In distribution | ||
| 67-6024 | In distribution | ||
| 79-1010 | In distribution | ||
| 22-8824 | In distribution | ||
| 67-6025 | In distribution | ||
| 67-6061 | In distribution | ||
| 67-6117 | In distribution | ||
| 67-6037 | In distribution | ||
| 67-6082 | In distribution | ||
| 70-1017 | In distribution | ||
| 67-6122 | In distribution | ||
| 70-1091 | In distribution | ||
| 67-6046 | In distribution | ||
| 41-1195 | In distribution | ||
| 67-6166 | In distribution | ||
| 70-9197 | In distribution | ||
| 67-6062 | In distribution | ||
| 67-6121 | In distribution | ||
| 79-1005 | In distribution | ||
| 67-6065 | In distribution | ||
| 67-6057 | In distribution | ||
| 67-6005 | In distribution | ||
| 67-6146 | 6 | In distribution | |
| 67-6147 | 6 | In distribution | |
| 90-2392 | In distribution | ||
| 67-6161 | In distribution | ||
| 70-9251 | In distribution | ||
| 67-6089 | In distribution | ||
| 70-9242 | In distribution | ||
| 41-1191 | In distribution | ||
| 70-9253 | In distribution | ||
| 67-6126 | In distribution | ||
| 96-2238 | 25 | In distribution | |
| 41-1192 | In distribution | ||
| 67-6165 | In distribution | ||
| 67-6092 | In distribution | ||
| 22-8826 | In distribution | ||
| 67-6160 | In distribution | ||
| 21-258 | 12 | In distribution | |
| 70-1065 | In distribution | ||
| 67-6074 | In distribution | ||
| 67-6124 | In distribution | ||
| 67-6162 | In distribution | ||
| 70-1063 | In distribution | ||
| 67-6163 | In distribution | ||
| 67-6036 | In distribution | ||
| 67-6003 | In distribution | ||
| 41-1197 | In distribution | ||
| 67-6054 | In distribution | ||
| 70-1072C | In distribution | ||
| 70-9198 | In distribution | ||
| 70-1071C | In distribution | ||
| 67-6038 | In distribution | ||
| 67-6114 | In distribution | ||
| 79-1006 | In distribution | ||
| 70-9252 | In distribution | ||
| 98-258 | In distribution | ||
| 70-9266 | In distribution | ||
| 70-1082 | In distribution | ||
| 67-6083 | In distribution | ||
| 67-6081 | In distribution | ||
| 79-1001 | In distribution | ||
| 70-9267 | In distribution | ||
| 67-6085 | In distribution | ||
| 67-6145 | 6 | In distribution | |
| 67-6014 | In distribution | ||
| 95-267 | In distribution | ||
| 67-6015 | In distribution | ||
| 41-1190 | In distribution | ||
| 70-1051 | In distribution | ||
| 67-6066 | In distribution | ||
| 67-6029 | In distribution | ||
| 67-6044 | In distribution | ||
| 67-6050 | In distribution | ||
| 67-6116 | In distribution | ||
| 67-6048 | In distribution | ||
| 70-1092 | In distribution | ||
| 67-6045 | In distribution | ||
| 67-6204 | In distribution | ||
| 67-6144 | 6 | In distribution | |
| 70-9232 | In distribution | ||
| 67-6007 | In distribution | ||
| 67-6039 | In distribution | ||
| 70-1086 | In distribution | ||
| 67-6013 | In distribution | ||
| 67-6070 | In distribution | ||
| 79-1003 | In distribution | ||
| 70-1081 | In distribution | ||
| 67-6090 | In distribution | ||
| 67-6053 | In distribution | ||
| 67-6016 | In distribution | ||
| 96-2237M | 25 | In distribution | |
| 67-6111 | In distribution | ||
| 67-6040 | In distribution | ||
| 67-6164 | In distribution | ||
| 70-1071 | In distribution | ||
| 79-1011 | In distribution | ||
| 67-6113 | In distribution | ||
| 96-0670 | 48 | In distribution | |
| 67-6055 | In distribution | ||
| 70-9265 | In distribution | ||
| 67-6088 | In distribution | ||
| 67-6094 | In distribution | ||
| 67-6071 | In distribution | ||
| 96-2236 | 25 | In distribution | |
| 70-1066 | In distribution | ||
| 67-6011 | In distribution | ||
| 67-6250 | In distribution | ||
| 67-6202 | In distribution | ||
| 95-258 | In distribution | ||
| 67-6006 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 203 |
| Ambler Surgical | Ambler Surgical, LLC | 190 |
| Aesculap | Aesculap AG | 170 |
| Boss Instruments | Boss Instruments, Ltd. | 161 |
| Fentex | Fentex medical GmbH | 157 |
| Millennium | Avalign Technologies, Inc. | 148 |
| Bear | Bear-ENT, LLC | 145 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 142 |
| BR Surgical, LLC | BR Surgical LLC | 133 |
| Surtex | Surtex Instruments Ltd | 110 |
| Jedmed | Jedmed Instrument Company | 106 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 104 |
Showing 12 of 260. All products under Speculum, Ent
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Sklar Corporation | UDI-DI | 2024-12-03 | Class II | Under Investigation by firm | Reports of various packaging issues that may result in a breach of the sterile barrier. | 175 units |
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.