Helmut Zepf
Bone Expander System SET Consisting OF Expander Screws With Accessories IN Washbasket 1/3
14manufacturers in China registered for this device type
26catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (3), Shandong (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Shandong Weigao Orthopaedic Device Co., Ltd. | Weihai | Shandong | Contract manufacturer | 42 |
| Xinhua Healthcare Industry Co., Limited | Zibo | Shandong | Contract manufacturer | 30 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Medtronic (Changzhou) Medical Devices Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 53 |
| Beijing Fule Science & Technology Development Co., Ltd. | Beijing | Beijing | Manufacturer | 31 |
| Shanghai Reach Medical Instrument Co., Ltd. | Shanghai | Shanghai | Manufacturer | 30 |
Showing 12 of 14. All 14 manufacturers in China registered for Wrench
Record
| Listed by | Helmut Zepf Medizintechnik Gmbh, Germany |
|---|---|
| FDA product code | HXC |
| Device type | Wrench |
| Device class | Class 1 |
| Regulation | 21 CFR 888.4540 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-12-07 |
| Record revised | 2023-11-30 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 47.833.06 | In distribution | |
| 47.832.05 | In distribution | |
| 47.833.05 | In distribution | |
| 47.833.08 | In distribution | |
| 47.832.04 | In distribution | |
| 47.830.06 | In distribution | |
| 47.525.55 | In distribution | |
| 47.803.02 | In distribution | |
| 47.565.01 | In distribution | |
| 47.833.04 | In distribution | |
| 47.832.06 | In distribution | |
| 46.007.11 | In distribution | |
| 47.832.07 | In distribution | |
| 47.565.02 | In distribution | |
| 47.830.05 | In distribution | |
| 47.832.09 | In distribution | |
| 47.832.01 | In distribution | |
| 47.833.07 | In distribution | |
| 47.832.03 | In distribution | |
| 47.832.08 | In distribution | |
| 47.833.01 | In distribution | |
| 47.832.02 | In distribution | |
| 47.833.03 | In distribution | |
| 47.565.00 | In distribution | |
| 47.830.00 | In distribution | |
| 47.833.02 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medtronic Reusable Instruments | Medtronic Sofamor Danek, Inc. | 85 |
| Wrench | Synthes Gmbh | 80 |
| Smart Correction | Wishbone Medical Inc. | 25 |
| Pinnacle Gription TF | Depuy (Ireland) | 23 |
| Karl Schumacher | Karl Schumacher Dental, LLC | 21 |
| Mega Plus Spine System | BK Meditech Co., Ltd. | 20 |
| Kalitec Universal Instruments | Kalitec Direct, LLC | 19 |
| Medtronic Resuable Instruments | Medtronic Sofamor Danek, Inc. | 17 |
| X FIX | Biomet Orthopedics | 15 |
| Global Steptech APG | Depuy Orthopaedics, Inc. | 14 |
| Wrench | Zimmer, Inc. | 14 |
| Pinnacle | Depuy (Ireland) | 13 |
Showing 12 of 388. All products under Wrench
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.