Sklar®
Moynihan Gall Stone Probes 13 Inches
12manufacturers in China registered for this device type
136catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Shanghai (4), Jiangsu (4), Shandong (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| Shanghai KiNETIC Medical Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Hangzhou Haizhu MIM Products Co., Ltd. | Hangzhou | Zhejiang | Exporter | 28 |
| Suzhou Endophix Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 17 |
| Hangzhou Ruihao Medical Technology Ltd | Hangzhou | Zhejiang | Contract manufacturer | 12 |
| Changzhou Xietong Industries Co., Ltd. | Changzhou | Jiangsu | Exporter | 11 |
Record
| Listed by | Sklar Corporation, United States |
|---|---|
| FDA product code | HXB |
| Device type | Probe |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-08-01 |
| Record revised | 2019-03-21 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 30-2457 | In distribution | ||
| 30-1170 | In distribution | ||
| 65-4123 | In distribution | ||
| 41-982 | In distribution | ||
| 30-1970 | In distribution | ||
| 65-4103 | In distribution | ||
| 41-1201 | In distribution | ||
| 32-3195 | In distribution | ||
| 65-4121 | In distribution | ||
| 30-1155 | In distribution | ||
| 30-1510 | In distribution | ||
| 65-4129 | In distribution | ||
| 98-200 | In distribution | ||
| 30-1560 | In distribution | ||
| 30-1480 | In distribution | ||
| 49-0855 | In distribution | ||
| 30-1180 | In distribution | ||
| 30-1021 | In distribution | ||
| 65-4140 | In distribution | ||
| 49-0800 | In distribution | ||
| 30-1550 | In distribution | ||
| 47-3525 | In distribution | ||
| 65-4128 | In distribution | ||
| 30-2010 | In distribution | ||
| 65-4165 | In distribution | ||
| 30-1030 | In distribution | ||
| 30-1145 | In distribution | ||
| 47-2590 | In distribution | ||
| 30-1211 | In distribution | ||
| 49-0865 | In distribution | ||
| 30-1612 | In distribution | ||
| 30-1610 | In distribution | ||
| 30-1518 | In distribution | ||
| 21-502 | 12 | In distribution | |
| 65-4106 | In distribution | ||
| 49-0860 | In distribution | ||
| 49-0835 | In distribution | ||
| 47-3524 | In distribution | ||
| 65-4161 | In distribution | ||
| 95-499 | In distribution | ||
| 26-1950 | In distribution | ||
| 30-1370 | In distribution | ||
| 30-1530 | In distribution | ||
| 30-1522 | In distribution | ||
| 65-4127 | In distribution | ||
| 48-885 | In distribution | ||
| 49-0810 | In distribution | ||
| 96-2361 | 25 | In distribution | |
| 30-1460 | In distribution | ||
| 30-1212 | In distribution | ||
| 98-508 | In distribution | ||
| 65-4141 | In distribution | ||
| 65-3343 | In distribution | ||
| 65-4107 | In distribution | ||
| 32-3196 | In distribution | ||
| 47-3526 | In distribution | ||
| 30-1524 | In distribution | ||
| 65-4102 | In distribution | ||
| 30-1545 | In distribution | ||
| 65-4125 | In distribution | ||
| 65-4099 | In distribution | ||
| 30-1528 | In distribution | ||
| 95-502 | In distribution | ||
| 65-3341 | In distribution | ||
| 30-1555 | In distribution | ||
| 65-4100 | In distribution | ||
| 30-1520 | In distribution | ||
| 30-1250 | In distribution | ||
| 49-0825 | In distribution | ||
| 65-4105 | In distribution | ||
| 65-4150 | In distribution | ||
| 49-0845 | In distribution | ||
| 30-1410 | In distribution | ||
| 49-0830 | In distribution | ||
| 30-1214 | In distribution | ||
| 30-1150 | In distribution | ||
| 65-3342 | In distribution | ||
| 30-1450 | In distribution | ||
| 49-0805 | In distribution | ||
| 30-1980 | In distribution | ||
| 65-4164 | In distribution | ||
| 30-1580 | In distribution | ||
| 49-0840 | In distribution | ||
| 30-1040 | In distribution | ||
| 30-1455 | In distribution | ||
| 65-4162 | In distribution | ||
| 30-1240 | In distribution | ||
| 65-4104 | In distribution | ||
| 30-2461 | In distribution | ||
| 30-1470 | In distribution | ||
| 21-499 | 12 | In distribution | |
| 65-4101 | In distribution | ||
| 30-1945 | In distribution | ||
| 98-499 | In distribution | ||
| 30-2145 | In distribution | ||
| 65-4151 | In distribution | ||
| 30-1960 | In distribution | ||
| 65-4163 | In distribution | ||
| 65-4158 | In distribution | ||
| 30-2150 | In distribution | ||
| 65-4160 | In distribution | ||
| 32-3194 | In distribution | ||
| 65-3340 | In distribution | ||
| 41-994 | In distribution | ||
| 30-1504 | In distribution | ||
| 30-1955 | In distribution | ||
| 41-952 | In distribution | ||
| 30-2160 | In distribution | ||
| 30-1508 | In distribution | ||
| 65-4097 | In distribution | ||
| 65-4170 | In distribution | ||
| 98-502 | In distribution | ||
| 30-1160 | In distribution | ||
| 65-4159 | In distribution | ||
| 65-4143 | In distribution | ||
| 30-1512 | In distribution | ||
| 32-3198 | In distribution | ||
| 49-0850 | In distribution | ||
| 30-1213 | In distribution | ||
| 30-2012 | In distribution | ||
| 30-1502 | In distribution | ||
| 30-1526 | In distribution | ||
| 41-972 | In distribution | ||
| 65-4166 | In distribution | ||
| 30-1372 | In distribution | ||
| 30-1506 | In distribution | ||
| 96-2361M | 25 | In distribution | |
| 49-0820 | In distribution | ||
| 30-1514 | In distribution | ||
| 49-0815 | In distribution | ||
| 30-1570 | In distribution | ||
| 41-1202 | In distribution | ||
| 30-1950 | In distribution | ||
| 30-2155 | In distribution | ||
| 30-1020 | In distribution | ||
| 65-4142 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 219 |
| Probe | Depuy Spine, Inc. | 190 |
| Probe | Zimmer Trabecular Metal Technology, Inc. | 154 |
| General Instruments | Alphatec Spine, Inc. | 112 |
| Life Instruments | Life Instrument Corp. | 107 |
| Tecomet | Tecomet, Inc. | 97 |
| Tetris ST | Signus Medizintechnik Gmbh | 65 |
| Invictus | Alphatec Spine, Inc. | 64 |
| Medtronic Resuable Instruments | Medtronic Sofamor Danek, Inc. | 56 |
| Probe | Synthes Gmbh | 47 |
| Tasmin R | Signus Medizintechnik Gmbh | 47 |
| Probe | Doppkon Gmbh & Co. KG | 41 |
Showing 12 of 330. All products under Probe
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. | 2500 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.