Elite
ELITE Needle Holder, Self Righting, 5mm, 45cm
7manufacturers in China registered for this device type
8catalogue numbers in this listing
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 | National Advanced Endoscopy Devices, Inc., United States |
|---|---|
| FDA product code | NWV |
| Device type | Laparoscopic Accessories, Gynecologic |
| Device class | Class 1 |
| Regulation | 21 CFR 884.1720 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-04-26 |
| Record revised | 2021-01-08 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ETH1592SR-45 | In distribution | |
| ETH1592SR | In distribution | |
| ETH1593 | In distribution | |
| ETH1594 | In distribution | |
| ETH1592 | In distribution | |
| ETH1592-45 | In distribution | |
| ETH1593-45 | In distribution | |
| ETH1594-45 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Millennium | Avalign Technologies, Inc. | 201 |
| AED | National Advanced Endoscopy Devices, Inc. | 173 |
| Elmed | Elmed, Inc. | 36 |
| 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 |
| Laparoscopic Accessories, Gynecologic | Richard Wolf Gmbh | 3 |
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.