VIA
The VIA procedure kit-custom includes transport pad, gauze pads, basin, enzymatic sponge, syringe, biohazard sticker, lubricating jelly, gown, DuoSwift combination squeegee brush, and…
The VIA procedure kit-custom includes transport pad, gauze pads, basin, enzymatic sponge, syringe, biohazard sticker, lubricating jelly, gown, DuoSwift combination squeegee brush, and BioGuard air water and suction valves 4 piece kit.
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 | Us Endoscopy, United States |
|---|---|
| FDA product code | NWW |
| Device type | Hysteroscope Accessories |
| Device class | Class 1 |
| Regulation | 21 CFR 884.1690 |
| Premarket notification | Exempt |
| Record published | 2018-09-20 |
| Record revised | 2020-02-03 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 12 |
| Distribution end date | 2020-02-03 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00717113 | Withdrawn |
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.