DeRoyal
Laparoscopic Scope Warmer
7manufacturers in China registered for this device type
2catalogue 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 | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | NWV |
| Device type | Laparoscopic Accessories, Gynecologic |
| Device class | Class 1 |
| Regulation | 21 CFR 884.1720 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-07-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TM500DE | In distribution | |
| TM500D | 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 |
| 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.