HYST/USH/1DBH/Ø2,9/302/30/TL/WE/COVIDIEN
Catalogue number 8300057946, listed by Henke-Sass Wolf, Gmbh., Germany, under Hysteroscope Accessories. 11 manufacturers in China are registered for this product code.
11manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (5), Guangdong (3), Jiangsu (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangdong MacroLux Medical Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
| Anhui Shiyin Photoelectric Instrument Co., Ltd. | Suzhou | Anhui | Specification developer | 18 |
| Zhuji Pengtian Medical Instrument Co., Ltd. | Zhuji | Zhejiang | Manufacturer | 10 |
| Macrolux Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Guangzhou RED Pine Medical Instrument Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 8 |
| Suzhou Acuvu Medical Technology Co., Ltd. | Suzhou | Jiangsu | Specification developer | 4 |
| Jiangsu Jiyuan Medical Technology Co., Ltd. | Taizhou | Jiangsu | Specification developer | 3 |
| Origyn Medical Technology (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Specification developer | 2 |
Record
| Listed by | Henke-Sass Wolf, Gmbh., Germany |
|---|---|
| FDA product code | NWW |
| Device type | Hysteroscope Accessories |
| Device class | Class 1 |
| Regulation | 21 CFR 884.1690 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-12-16 |
| Record revised | 2023-11-17 (version 2) |
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, manufacturing date |
| Sizes | Outer diameter 4 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8300057946 | Outer Diameter 4.0 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Millennium | Avalign Technologies, Inc. | 55 |
| OriGynMED | Origyn Medical Technology (Hangzhou) Co., Ltd. | 36 |
| Elmed | Elmed, Inc. | 33 |
| Strauss Surgical | American Medical Endoscopy | 16 |
| Olympus | Olympus Winter & IBE Gmbh | 9 |
| Clickline | Karl Storz GmbH & Co. KG | 9 |
| Hysteroscope Accessories | Karl Storz GmbH & Co. KG | 8 |
| Hysteroscope Accessories | Henke-Sass Wolf, Gmbh. | 7 |
| Elmed Incorporated | Elmed, Inc. | 6 |
| Hermann Medizintechnik GmbH | Hermann Medizintechnik Gmbh | 5 |
| Hysteroscope Accessories | Boston Scientific Corporation | 4 |
| Pneumostop® | LSI Solutions Inc. | 4 |
Showing 12 of 50. All products under Hysteroscope Accessories
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.