Helmut Zepf
Retractor, Whale FIN ACC. DR Maty Size 1, 30MM Width, Sterilizable IN Bionik Handle Torquoise-Brightblue
45manufacturers in China registered for this device type
83catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (10), Zhejiang (8), Shanghai (6). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Senlede Technologies Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 33 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Hangzhou Westlake Biomaterial Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 13 |
| Xiamen Yizhou IMP. & EXP. Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 10 |
| Dongguan Junhai Medical Device Co., Ltd. | Dong Guang | Guangdong | Contract manufacturer | 9 |
| Forefront (Xiamen) Medical Devices Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 8 |
| Taizhou Polus Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 2 |
| Talent Technology Mould Co., Limited | Shenzhen | Guangdong | Contract manufacturer | 1 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
Showing 12 of 45. All 45 manufacturers in China registered for Retractor, All Types
Record
| Listed by | Helmut Zepf Medizintechnik Gmbh, Germany |
|---|---|
| FDA product code | EIG |
| Device type | Retractor, All Types |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-11-25 |
| Record revised | 2024-02-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 41.960.23WL | In distribution | |
| 37.457.01TI | In distribution | |
| 38.428.22 | In distribution | |
| 37.446.06 | In distribution | |
| 38.430.01 | In distribution | |
| 41.960.01 | In distribution | |
| 38.438.04 | In distribution | |
| 38.428.06 | In distribution | |
| 37.457.00 | In distribution | |
| 37.441.02 | In distribution | |
| 38.430.03 | In distribution | |
| 38.427.22 | In distribution | |
| 41.960.12WL | In distribution | |
| 38.426.04 | In distribution | |
| 41.960.01WL | In distribution | |
| 38.426.03 | In distribution | |
| 38.426.09 | In distribution | |
| 41.960.13WL | In distribution | |
| 37.441.01 | In distribution | |
| 37.440.00 | In distribution | |
| 38.428.02 | In distribution | |
| 38.427.01 | In distribution | |
| 38.428.05 | In distribution | |
| 37.429.14 | In distribution | |
| 37.446.07 | In distribution | |
| 38.426.06K | In distribution | |
| 37.426.02 | In distribution | |
| 41.960.11WL | In distribution | |
| 37.457.00TI | In distribution | |
| 37.454.02 | In distribution | |
| 37.438.15 | In distribution | |
| 38.426.06 | In distribution | |
| 38.430.06 | In distribution | |
| 38.430.05 | In distribution | |
| 37.446.04E | In distribution | |
| 37.438.10 | In distribution | |
| 37.457.02 | In distribution | |
| 38.445.04 | In distribution | |
| 38.427.02 | In distribution | |
| 38.445.07 | In distribution | |
| 37.448.35 | In distribution | |
| 38.438.06 | In distribution | |
| 37.454.00 | In distribution | |
| 38.445.06 | In distribution | |
| 37.437.17 | In distribution | |
| 37.448.30 | In distribution | |
| 38.426.05 | In distribution | |
| 38.426.01 | In distribution | |
| 37.446.04 | In distribution | |
| 37.445.02HZU | In distribution | |
| 37.426.01 | In distribution | |
| 38.078.16 | In distribution | |
| 38.438.03 | In distribution | |
| 37.429.12 | In distribution | |
| 38.467.10 | In distribution | |
| 37.443.00 | In distribution | |
| 38.050.03 | In distribution | |
| 38.430.02 | In distribution | |
| 38.426.08 | In distribution | |
| 38.448.50 | In distribution | |
| 37.437.15 | In distribution | |
| 38.426.07 | In distribution | |
| 38.445.02 | In distribution | |
| 37.457.01 | In distribution | |
| 38.465.15 | In distribution | |
| 38.428.03 | In distribution | |
| 38.074.14 | In distribution | |
| 38.438.07 | In distribution | |
| 37.429.16 | In distribution | |
| 38.452.00 | In distribution | |
| 41.960.02WL | In distribution | |
| 38.467.08 | In distribution | |
| 38.076.16 | In distribution | |
| 38.438.02 | In distribution | |
| 38.426.02 | In distribution | |
| 37.445.01 | In distribution | |
| 38.430.04 | In distribution | |
| 41.960.03WL | In distribution | |
| 38.438.05 | In distribution | |
| 37.457.02TI | In distribution | |
| 38.428.04 | In distribution | |
| 38.445.05 | In distribution | |
| 37.444.01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 340 |
| Retractor, All Types | George Tiemann & Co. | 218 |
| Retractor | KLS-Martin L.P. | 210 |
| Zoll-Dental | Zoll-Dental | 110 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 90 |
| ACE | Ace Surgical Supply Co., Inc. | 88 |
| Millennium | Avalign Technologies, Inc. | 86 |
| Retractor, All Types | Biomet Microfixation | 78 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 63 |
| Kohdent | Kohler Medizintechnik GmbH | 61 |
| Power Dental USA | Power Dental U.S.A. Inc. | 59 |
| Boss Instruments | Boss Instruments, Ltd. | 54 |
Showing 12 of 336. All products under Retractor, All Types
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.