Sklar®
Censitrac Ready Corwin Wire Twis Serr FL 6 Inches TC
15manufacturers in China registered for this device type
675catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (5), Zhejiang (3), Shanghai (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Anhui Medpurest Medical Technology Co., Ltd. | Anqing | Anhui | Manufacturer | 46 |
| Anqing Kangmingna Packaging Co., Ltd. | Anqing | Anhui | Contract manufacturer | 39 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Suzhou Microport Orthorecon Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 31 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
| Ningbo Yingmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 29 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
| Huaian Tisurg Medical Instruments Co., Ltd. | Huaian | Jiangsu | Contract manufacturer | 22 |
Showing 12 of 15. All 15 manufacturers in China registered for Holder, Needle; Orthopedic
Record
| Listed by | Sklar Corporation, United States |
|---|---|
| FDA product code | HXK |
| Device type | Holder, Needle; Orthopedic |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-07-10 |
| Record revised | 2021-01-08 (version 4) |
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 |
|---|---|---|---|
| 21-8059 | In distribution | ||
| 21-8042C | In distribution | ||
| 20-1280C | In distribution | ||
| 95-149 | In distribution | ||
| 98-9333 | In distribution | ||
| 21-8037C | In distribution | ||
| 21-8055C | In distribution | ||
| 98-9310 | In distribution | ||
| 20-2641 | In distribution | ||
| 21-8058 | In distribution | ||
| 21-8006C | In distribution | ||
| 21-9051 | In distribution | ||
| 65-6371T | In distribution | ||
| 98-3141 | In distribution | ||
| 20-4175 | In distribution | ||
| 21-8081 | In distribution | ||
| 98-4312T | In distribution | ||
| 98-3140 | In distribution | ||
| 95-147 | In distribution | ||
| 21-9018C | In distribution | ||
| 98-9320 | In distribution | ||
| 98-9347 | In distribution | ||
| 95-132 | In distribution | ||
| 21-8090C | In distribution | ||
| 20-1870C | In distribution | ||
| 21-8010 | In distribution | ||
| 20-8066 | In distribution | ||
| 23-2135 | In distribution | ||
| 21-2060C | In distribution | ||
| 20-2747 | In distribution | ||
| 21-8139 | In distribution | ||
| 21-1450 | In distribution | ||
| 65-6452 | In distribution | ||
| 21-8031 | In distribution | ||
| 96-3927 | 10 | In distribution | |
| 23-2220 | In distribution | ||
| 21-8066 | In distribution | ||
| 21-885 | 12 | In distribution | |
| 20-1265C | In distribution | ||
| 21-9012 | In distribution | ||
| 23-2225 | In distribution | ||
| 98-9330 | In distribution | ||
| 98-4305T | In distribution | ||
| 96-2590M | 50 | In distribution | |
| 65-6370T | In distribution | ||
| 96-2353M | 25 | In distribution | |
| 95-134 | In distribution | ||
| 65-6345 | In distribution | ||
| 21-8052 | In distribution | ||
| 21-8045 | In distribution | ||
| 20-1295 | In distribution | ||
| 21-2914C | In distribution | ||
| 96-2594M | 50 | In distribution | |
| 21-8130 | In distribution | ||
| 23-2132 | In distribution | ||
| 20-2490C | In distribution | ||
| 98-9337 | In distribution | ||
| 21-8102 | In distribution | ||
| 20-4795C | In distribution | ||
| 95-810 | In distribution | ||
| 98-9332 | In distribution | ||
| 20-3075 | In distribution | ||
| 95-140 | In distribution | ||
| 21-8037 | In distribution | ||
| 20-1551 | In distribution | ||
| 21-8000C | In distribution | ||
| 21-8075C | In distribution | ||
| 21-812 | 12 | In distribution | |
| 98-3188 | In distribution | ||
| 95-137 | In distribution | ||
| 21-5003 | In distribution | ||
| 21-8008C | In distribution | ||
| 98-4308T | In distribution | ||
| 98-3176 | In distribution | ||
| 21-8014 | In distribution | ||
| 21-8159 | In distribution | ||
| 61-0200 | In distribution | ||
| 21-8111 | In distribution | ||
| 21-8257 | In distribution | ||
| 20-2740 | In distribution | ||
| 20-2662 | In distribution | ||
| 95-853 | In distribution | ||
| 21-2240 | In distribution | ||
| 98-4304T | In distribution | ||
| 21-8028C | In distribution | ||
| 65-6358 | In distribution | ||
| 96-8968 | 50 | In distribution | |
| 20-1260 | In distribution | ||
| 20-2270 | In distribution | ||
| 21-8008 | In distribution | ||
| 23-2134 | In distribution | ||
| 21-4955 | In distribution | ||
| 98-3182 | In distribution | ||
| 21-2480 | In distribution | ||
| 20-1350C | In distribution | ||
| 21-8088 | In distribution | ||
| 21-8118 | In distribution | ||
| 97-894 | In distribution | ||
| 21-8019C | In distribution | ||
| 21-826 | 12 | In distribution | |
| 23-2136 | In distribution | ||
| 96-2353 | 25 | In distribution | |
| 21-8105 | In distribution | ||
| 65-6450 | In distribution | ||
| 20-3350 | In distribution | ||
| 98-3149 | In distribution | ||
| 21-8059C | In distribution | ||
| 98-3166 | In distribution | ||
| 21-8065 | In distribution | ||
| 98-3165 | In distribution | ||
| 21-2060 | In distribution | ||
| 21-8061C | In distribution | ||
| 96-2584 | 50 | In distribution | |
| 65-6552 | In distribution | ||
| 21-8094 | In distribution | ||
| 21-8009C | In distribution | ||
| 21-8093 | In distribution | ||
| 21-9016 | In distribution | ||
| 21-2664 | In distribution | ||
| 94-8061 | In distribution | ||
| 21-8027C | In distribution | ||
| 97-813 | In distribution | ||
| 95-834 | In distribution | ||
| 20-2311 | In distribution | ||
| 98-3177 | In distribution | ||
| 23-2130 | In distribution | ||
| 65-6454 | In distribution | ||
| 21-8096 | In distribution | ||
| 98-4308TC | In distribution | ||
| 20-2781 | In distribution | ||
| 21-8021C | In distribution | ||
| 21-4914 | In distribution | ||
| 21-4959 | In distribution | ||
| 97-838 | In distribution | ||
| 23-2235 | In distribution | ||
| 98-4303T | In distribution | ||
| 65-6382 | In distribution | ||
| 21-2070C | In distribution | ||
| 98-9306 | In distribution | ||
| 21-2570 | In distribution | ||
| 21-5114 | In distribution | ||
| 21-8012 | In distribution | ||
| 21-2790 | In distribution | ||
| 95-138 | In distribution | ||
| 21-8043C | In distribution | ||
| 82635 | In distribution | ||
| 96-2587 | 25 | In distribution | |
| 21-4953 | In distribution | ||
| 98-9350 | In distribution | ||
| 21-8016C | In distribution | ||
| 98-7820 | In distribution | ||
| 97-885 | In distribution | ||
| 20-2060 | In distribution | ||
| 21-8013C | In distribution | ||
| 21-1260 | In distribution | ||
| 65-6346 | In distribution | ||
| 21-1549 | In distribution | ||
| 21-8044 | In distribution | ||
| 95-146 | In distribution | ||
| 98-9355 | In distribution | ||
| 21-2796 | In distribution | ||
| 98-9352 | In distribution | ||
| 21-8000 | In distribution | ||
| 20-1295C | In distribution | ||
| 20-4840 | In distribution | ||
| 21-8040C | In distribution | ||
| 95-869 | In distribution | ||
| 21-4963 | In distribution | ||
| 20-1760 | In distribution | ||
| 21-2175 | In distribution | ||
| 20-2480 | In distribution | ||
| 21-8030 | In distribution | ||
| 96-2417 | 25 | In distribution | |
| 98-4314T | In distribution | ||
| 82620 | In distribution | ||
| 96-2355M | 25 | In distribution | |
| 21-8251 | In distribution | ||
| 94-8195 | In distribution | ||
| 21-8072 | In distribution | ||
| 97-869 | In distribution | ||
| 20-1751C | In distribution | ||
| 21-8005 | In distribution | ||
| 21-9050 | In distribution | ||
| 65-6457 | In distribution | ||
| 96-2585M | 25 | In distribution | |
| 20-2662C | In distribution | ||
| 21-8012C | In distribution | ||
| 21-7013 | In distribution | ||
| 23-2237 | In distribution | ||
| 65-6357C | In distribution | ||
| 95-842 | In distribution | ||
| 26-1895 | In distribution | ||
| 98-9302 | In distribution | ||
| 20-2640 | In distribution | ||
| 97-826 | In distribution | ||
| 98-3167 | In distribution | ||
| 21-8011 | In distribution | ||
| 21-8136 | In distribution | ||
| 21-1650 | In distribution | ||
| 96-2595M | 25 | In distribution | |
| 95-872 | In distribution | ||
| 21-8041 | In distribution | ||
| 20-4841 | In distribution | ||
| 96-2591M | 25 | In distribution | |
| 61-0202 | In distribution | ||
| 21-8034C | In distribution | ||
| 20-2748 | In distribution | ||
| 23-2125 | In distribution | ||
| 21-8056 | In distribution | ||
| 98-3170 | In distribution | ||
| 97-809 | In distribution | ||
| 23-2124 | In distribution | ||
| 20-4510C | In distribution | ||
| 65-6053 | In distribution | ||
| 98-3193 | In distribution | ||
| 98-9327 | In distribution | ||
| 20-2755C | In distribution | ||
| 21-4958 | In distribution | ||
| 21-8051C | In distribution | ||
| 98-7847 | In distribution | ||
| 20-2725 | In distribution | ||
| 21-8023 | In distribution | ||
| 21-8062 | In distribution | ||
| 21-4952 | In distribution | ||
| 65-6366 | In distribution | ||
| 98-9321 | In distribution | ||
| 98-9331 | In distribution | ||
| 21-9030 | In distribution | ||
| 20-2048 | In distribution | ||
| 95-838 | In distribution | ||
| 21-8032C | In distribution | ||
| 96-3926 | 10 | In distribution | |
| 82610 | In distribution | ||
| 21-8104 | In distribution | ||
| 21-3100 | In distribution | ||
| 21-8101 | In distribution | ||
| 21-8072C | In distribution | ||
| 82600 | In distribution | ||
| 21-1547 | In distribution | ||
| 82615 | In distribution | ||
| 95-847 | In distribution | ||
| 21-8046 | In distribution | ||
| 21-8109 | In distribution | ||
| 95-130 | In distribution | ||
| 98-9340 | In distribution | ||
| 61-1202 | In distribution | ||
| 98-7786 | In distribution | ||
| 21-1850C | In distribution | ||
| 98-9315 | In distribution | ||
| 21-8073 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Needle Holder | KLS-Martin L.P. | 183 |
| Anmuth Medical International | Anmuth Medical International LLC | 148 |
| gSource | Gsource, LLC. | 147 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 139 |
| Orthomed | Ortho-MED, Inc. | 134 |
| Holder, Needle; Orthopedic | Fehling Instruments GmbH | 119 |
| Marina Medical | Marina Medical Instruments, Inc. | 115 |
| Durogrip | Aesculap AG | 78 |
| Stephens Instruments | Krishna Imports Inc | 77 |
| Aesculap | Aesculap AG | 73 |
| Diadust | Aesculap AG | 71 |
| Zoll-Dental | Zoll-Dental | 64 |
Showing 12 of 158. All products under Holder, Needle; Orthopedic
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. | 41850 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.