Aptus
Impl.Cont. Hand 2.0/2.3 Compr. & TriLock
Who Else Makes It
Concentrated in Jiangsu (28), Zhejiang (23), Shanghai (16). 20 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Gcmedica Enterprise Ltd.(Wuxi) | Wuxi | Jiangsu | Contract manufacturer | 55 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | Danyang | Jiangsu | Contract manufacturer | 37 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Mobility Source Medical Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 26 |
| Guangdong Shunde LQX Health Technology Inc. | Foshan | Guangdong | Contract manufacturer | 24 |
Showing 12 of 105. All 105 manufacturers in China registered for Tray, Surgical, Instrument
Record
| Listed by | Medartis Inc., United States |
|---|---|
| FDA product code | FSM |
| Device type | Tray, Surgical, Instrument |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K243610 |
| Record published | 2023-02-24 |
| Record revised | 2024-11-01 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| A-0860.1 | In distribution | |
| A-6604.051 | In distribution | |
| A-6025 | In distribution | |
| A-0854.21 | In distribution | |
| A-6505 | In distribution | |
| A-6604.060 | In distribution | |
| A-6095.68 | In distribution | |
| A-6095.05 | In distribution | |
| A-6531 | In distribution | |
| A-6517 | In distribution | |
| A-6095.65 | In distribution | |
| A-6604.122 | In distribution | |
| A-6076.06 | In distribution | |
| A-6501.14 | In distribution | |
| A-6603.023 | In distribution | |
| A-6572 | In distribution | |
| A-6604.051 | In distribution | |
| A-6602.049 | In distribution | |
| A-6099.07 | In distribution | |
| A-6501.07 | In distribution | |
| A-6099.06 | In distribution | |
| A-0881 | In distribution | |
| A-0732 | In distribution | |
| A-6095.13 | In distribution | |
| A-6602.056 | In distribution | |
| A-0734 | In distribution | |
| A-6602.075 | In distribution | |
| A-6095.76 | In distribution | |
| A-6603.004 | In distribution | |
| A-6601.009 | In distribution | |
| A-6590 | In distribution | |
| A-0760 | In distribution | |
| A-6533 | In distribution | |
| A-6604.060 | In distribution | |
| A-0856.20 | In distribution | |
| A-6602.059 | In distribution | |
| A-6622 | In distribution | |
| A-6024 | In distribution | |
| A-0844.10 | In distribution | |
| A-6601.002 | In distribution | |
| A-6095.73 | In distribution | |
| A-6573 | In distribution | |
| A-6604.110 | In distribution | |
| A-6501 | In distribution | |
| A-6602.026 | In distribution | |
| A-6552 | In distribution | |
| A-6602.028 | In distribution | |
| A-6095.74 | In distribution | |
| A-6604.116 | In distribution | |
| A-6604.231 | In distribution | |
| A-6603.026 | In distribution | |
| A-6009 | In distribution | |
| A-0849.20 | In distribution | |
| A-6602.016 | In distribution | |
| A-6601.014 | In distribution | |
| A-6010.18 | In distribution | |
| A-6095.77 | In distribution | |
| A-6605.007 | In distribution | |
| A-6603.052 | In distribution | |
| A-0894 | In distribution | |
| A-6621 | In distribution | |
| A-6603.053 | In distribution | |
| A-6010.16 | In distribution | |
| A-6601.011 | In distribution | |
| A-0772 | In distribution | |
| A-6603.521 | In distribution | |
| A-6604.225 | In distribution | |
| A-6603.011 | In distribution | |
| A-0854.11.1 | In distribution | |
| A-6610.60 | In distribution | |
| A-0761 | In distribution | |
| A-0716 | In distribution | |
| A-6602.021 | In distribution | |
| A-6603.721 | In distribution | |
| A-6601.005 | In distribution | |
| A-6530 | In distribution | |
| A-6602.005 | In distribution | |
| A-6604.103 | In distribution | |
| A-6602.070 | In distribution | |
| A-0854.21.1 | In distribution | |
| A-6602.017 | In distribution | |
| A-6601.003 | In distribution | |
| A-6501 | In distribution | |
| A-6095.66 | In distribution | |
| A-6574 | In distribution | |
| A-6602.016 | In distribution | |
| A-6551 | In distribution | |
| A-6602.065 | In distribution | |
| A-6604.050 | In distribution | |
| A-6604.106 | In distribution | |
| A-6604.161 | In distribution | |
| A-6604.147 | In distribution | |
| A-6010.12 | In distribution | |
| A-0859.10 | In distribution | |
| A-0877 | In distribution | |
| A-6604.052 | In distribution | |
| A-6602.024 | In distribution | |
| A-6601.012 | In distribution | |
| A-6095.73 | In distribution | |
| A-6603.521 | In distribution | |
| A-6603.042 | In distribution | |
| A-6501.12 | In distribution | |
| A-6026 | In distribution | |
| A-6508 | In distribution | |
| A-6585 | In distribution | |
| A-6575 | In distribution | |
| A-6602.051 | In distribution | |
| A-6538 | In distribution | |
| A-6602.025 | In distribution | |
| A-6513 | In distribution | |
| A-6601.014 | In distribution | |
| A-0853.20 | In distribution | |
| A-0853.10 | In distribution | |
| A-6095.77 | In distribution | |
| A-6095.13 | In distribution | |
| A-6570 | In distribution | |
| A-6604.145 | In distribution | |
| A-6601.004 | In distribution | |
| A-6604.233 | In distribution | |
| A-0510 | In distribution | |
| A-0895 | In distribution | |
| A-6602.005 | In distribution | |
| A-6604.912 | In distribution | |
| A-0853.20.1 | In distribution | |
| A-6530 | In distribution | |
| A-6601.012 | In distribution | |
| A-0762 | In distribution | |
| A-6602.013 | In distribution | |
| A-6602.021 | In distribution | |
| A-6600.006 | In distribution | |
| A-6604.113 | In distribution | |
| A-6600.004 | In distribution | |
| A-6623 | In distribution | |
| A-0852.10 | In distribution | |
| A-6507 | In distribution | |
| A-0715 | In distribution | |
| A-6602.057 | In distribution | |
| A-6095.82 | In distribution | |
| A-6501.22 | In distribution | |
| A-6603.013 | In distribution | |
| A-6605.010 | In distribution | |
| A-6501.03 | In distribution | |
| A-6602.012 | In distribution | |
| A-0847.10 | In distribution | |
| A-6603.021 | In distribution | |
| A-0853.21.1 | In distribution | |
| A-6602.055 | In distribution | |
| A-6610.11 | In distribution | |
| A-6099.20 | In distribution | |
| A-6602.064 | In distribution | |
| A-6024 | In distribution | |
| A-6522 | In distribution | |
| A-6604.135 | In distribution | |
| A-6620 | In distribution | |
| A-6095.61 | In distribution | |
| A-6522 | In distribution | |
| A-6604.149 | In distribution | |
| A-6604.912 | In distribution | |
| A-6501.19 | In distribution | |
| A-6602.035 | In distribution | |
| A-6501.18 | In distribution | |
| A-6600.007 | In distribution | |
| A-6604.913 | In distribution | |
| A-6095.75 | In distribution | |
| A-6603.023 | In distribution | |
| A-6603.041 | In distribution | |
| A-6095.62 | In distribution | |
| A-6604.104 | In distribution | |
| A-0893 | In distribution | |
| A-0722 | In distribution | |
| A-6099.23 | In distribution | |
| A-6603.042 | In distribution | |
| A-0853.70.1 | In distribution | |
| A-6602.027 | In distribution | |
| A-6070.48 | In distribution | |
| A-6601.003 | In distribution | |
| A-6610.10 | In distribution | |
| A-6603.511 | In distribution | |
| A-6602.033 | In distribution | |
| A-6604.232 | In distribution | |
| A-6602.002 | In distribution | |
| A-6020 | In distribution | |
| A-6602.071 | In distribution | |
| A-6602.057 | In distribution | |
| A-6603.731 | In distribution | |
| A-6095.71 | In distribution | |
| A-6602.076 | In distribution | |
| A-6514 | In distribution | |
| A-6520 | In distribution | |
| A-6604.119 | In distribution | |
| A-6519 | In distribution | |
| A-6601.001 | In distribution | |
| A-0810.10 | In distribution | |
| A-0883 | In distribution | |
| A-0846.10 | In distribution | |
| A-0725 | In distribution | |
| A-6095.63 | In distribution | |
| A-6535 | In distribution | |
| A-6601.005 | In distribution | |
| A-6604.130 | In distribution | |
| A-6602.050 | In distribution | |
| A-6603.511 | In distribution | |
| A-6604.165 | In distribution | |
| S-6001 | In distribution | |
| A-6600.003 | In distribution | |
| A-6600.010 | In distribution | |
| A-6095.72 | In distribution | |
| A-6604.133 | In distribution | |
| A-6601.004 | In distribution | |
| A-6095.66 | In distribution | |
| A-6604.131 | In distribution | |
| A-6604.132 | In distribution | |
| A-6603.053 | In distribution | |
| A-6602.001 | In distribution | |
| A-6586 | In distribution | |
| A-6604.141 | In distribution | |
| A-0857.10 | In distribution | |
| A-6605.012 | In distribution | |
| A-6500 | In distribution | |
| A-6604.146 | In distribution | |
| A-0849.10 | In distribution | |
| A-6602.022 | In distribution | |
| A-0810.32 | In distribution | |
| A-6095.65 | In distribution | |
| A-6583 | In distribution | |
| A-6604.126 | In distribution | |
| A-6501.13 | In distribution | |
| A-0880.1 | In distribution | |
| A-6095.69 | In distribution | |
| A-6602.001 | In distribution | |
| A-0765 | In distribution | |
| A-6602.031 | In distribution | |
| A-6621 | In distribution | |
| A-6603.051 | In distribution | |
| A-6583 | In distribution | |
| A-6604.155 | In distribution | |
| A-6603.731 | In distribution | |
| A-6500 | In distribution | |
| A-0714 | In distribution | |
| A-6009 | In distribution | |
| A-6602.018 | In distribution | |
| A-6604.115 | In distribution | |
| A-6574 | In distribution | |
| A-0896 | In distribution | |
| A-6508 | In distribution | |
| A-6603.014 | In distribution | |
| A-6525 | In distribution | |
| A-6602.050 | In distribution | |
| A-6099.15 | In distribution | |
| A-0851.30 | In distribution |
Showing 250 of 300 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| IMS | HU-Friedy MFG Co., LLC | 2,710 |
| Tray, Surgical, Instrument | Synthes Gmbh | 1,052 |
| Tray, Surgical, Instrument | Medtronic Sofamor Danek, Inc. | 1,012 |
| Hu-Friedy MFG Co., LLC. | HU-Friedy MFG Co., LLC | 666 |
| Acumed | Acumed LLC | 566 |
| Aesculap | Aesculap AG | 532 |
| Sklar | Sklar Corporation | 465 |
| Hu-Friedy | HU-Friedy MFG Co., LLC | 438 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 429 |
| Level ONE | KLS-Martin L.P. | 341 |
| Bahadir USA | Bahadir USA LLC | 300 |
| Devon | Cardinal Health | 254 |
Showing 12 of 3,212. All products under Tray, Surgical, Instrument
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.