Surgical Direct
Mister Clear fog reduction, Sterile, Single use, 1 units, Sample
7manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (3), Guangdong (3), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Global Medical Production Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 10 |
| Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | Cixi | Zhejiang | Manufacturer | 8 |
| Guangdong Optomedic Technologies, Inc. | Foshan | Guangdong | Manufacturer | 7 |
Record
| Listed by | Surgical Direct, Inc., United States |
|---|---|
| FDA product code | HET |
| Device type | Laparoscope, Gynecologic (And Accessories) |
| Device class | Class 2 |
| Regulation | 21 CFR 884.1720 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2022-12-02 |
| Record revised | 2024-04-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SD8031 | In distribution | |
| SD8031s | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endoplus | Endoplus | 448 |
| Integra® MicroFrance® | Integra Microfrance SAS | 273 |
| Symmetry Surgical® | Aspen Surgical Products, Inc. | 139 |
| Laparoscope, Gynecologic (And Accessories) | Karl Storz GmbH & Co. KG | 119 |
| Elmed | Elmed, Inc. | 96 |
| Olympus | Olympus Winter & IBE Gmbh | 71 |
| Core Dynamics | ConMed Corporation | 52 |
| Symmetry | Aspen Surgical Products, Inc. | 48 |
| DANmed | Dannoritzer Medizintechnik GmbH & Co. KG | 45 |
| Laparoscope, Gynecologic (And Accessories) | Richard Wolf Gmbh | 37 |
| Take-Apart | Karl Storz GmbH & Co. KG | 31 |
| Blueendo | Trokamed Gmbh | 28 |
Showing 12 of 396. All products under Laparoscope, Gynecologic (And 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.