Trinity Sterile, Inc.
Needle Holder Olsen Hegar 6"
15manufacturers in China registered for this device type
33catalogue numbers in this listing
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 | Trinity Sterile, Inc., United States |
|---|---|
| FDA product code | HXK |
| Device type | Holder, Needle; Orthopedic |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-08-29 |
| Record revised | 2023-12-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
| Packaging | Pack of 25, pack of 50, pack of 100 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7129 | In distribution | |
| 6007 | In distribution | |
| 6012 | In distribution | |
| 5092 | In distribution | |
| T97-832 | In distribution | |
| 7219 | In distribution | |
| 6017 | In distribution | |
| 6022 | In distribution | |
| 6019 | In distribution | |
| T97-872 | In distribution | |
| T97-853 | In distribution | |
| 5097 | In distribution | |
| 5091 | In distribution | |
| T97-810 | In distribution | |
| 7036 | In distribution | |
| 5094 | In distribution | |
| 6001 | In distribution | |
| 6018 | In distribution | |
| 7130 | In distribution | |
| 6006 | In distribution | |
| 6002 | In distribution | |
| 6008 | In distribution | |
| 6011 | In distribution | |
| 6024 | In distribution | |
| 6016 | In distribution | |
| 6014 | In distribution | |
| 7028 | In distribution | |
| 6023 | In distribution | |
| 5098 | In distribution | |
| T97-847 | In distribution | |
| 5099 | In distribution | |
| 6021 | In distribution | |
| 6000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar® | Sklar Corporation | 675 |
| 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 |
Showing 12 of 158. All products under Holder, Needle; Orthopedic
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.