Valve
Catalogue number MAJ-2025, listed by Olympus Medical Systems Corp., Japan, under Laparoscopic Accessories, Gynecologic. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (3), Anhui (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Tonglu Qianyan Medtech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Anhui Shiyin Photoelectric Instrument Co., Ltd. | Suzhou | Anhui | Specification developer | 18 |
| Tonglu Youshi Medical Instrument Co., Ltd. | Tonglu | Zhejiang | Manufacturer | 10 |
| Anqing Changfan Medical Instrument Co., Ltd. | Anqing | Anhui | Manufacturer | 9 |
| Suzhou SMH Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 4 |
| Hunan Handlike Minimally Invasive Surgery Co., Ltd. | Changsha | Hunan | Manufacturer | 3 |
Record
| Listed by | Olympus Medical Systems Corp., Japan |
|---|---|
| FDA product code | NWV |
| Device type | Laparoscopic Accessories, Gynecologic |
| Device class | Class 1 |
| Regulation | 21 CFR 884.1720 |
| Establishment | Specification developer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-09-21 |
| Record revised | 2024-07-25 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | High-level Disinfectant, Moist Heat or Steam Sterilization, Ethylene Oxide |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2022-08-15 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MAJ-2025 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Millennium | Avalign Technologies, Inc. | 201 |
| AED | National Advanced Endoscopy Devices, Inc. | 173 |
| Elmed | Elmed, Inc. | 36 |
| Elite | National Advanced Endoscopy Devices, Inc. | 8 |
| Elmed Incorporated | Elmed, Inc. | 7 |
| AbGrab | Lapovations, LLC | 6 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 5 |
| Laparoscopic Accessories, Gynecologic | Stryker Sustainability Solutions | 5 |
| Speedlock | National Advanced Endoscopy Devices, Inc. | 5 |
| TroClear | Mednium Corporation | 5 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 5 |
| Eco Fit | National Advanced Endoscopy Devices, Inc. | 4 |
Showing 12 of 80. All products under Laparoscopic Accessories, Gynecologic
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.