DeRoyal
5R200 Mirror Magic 100/ca
5manufacturers in China registered for this device type
7catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Guangdong (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jianerkang Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 18 |
| Shenzhen Jingxintai Houseware Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Shanghai Xodus Medical Company Limited | Shanghai | Shanghai | Specification developer | 25 |
| Shanghai Lejoy Co., Ltd. | Shanghai | Shanghai | Exporter | 21 |
| Changzhou Atomic HI-Tech Radiation Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 8 |
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | OCT |
| Device type | Anti Fog Solution And Accessories, Endoscopy |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-12 |
| Record revised | 2023-01-20 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 20, case of 100, case of 750, case of 4, case of 500 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 28-ZIRC | In distribution | |
| 28-0101B | In distribution | |
| FOGLIQUID | In distribution | |
| 28-0102 | In distribution | |
| 28-0102B | In distribution | |
| 28-0101 | In distribution | |
| V28-0101 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mr. Clear Purple | Mectra Labs, Inc. | 8 |
| Dr. Fog® Treated Sponge | Aspen Surgical Products, Inc. | 4 |
| Dr. Fog® Solution With Sponge | Aspen Surgical Products, Inc. | 2 |
| Merocel® Elvis® | Medtronic Xomed, Inc. | 2 |
| Aspen® Anti-fog Solution | Aspen Surgical Products, Inc. | 2 |
| Dr. Fog® Anti-fog Solution | Aspen Surgical Products, Inc. | 2 |
| Richard Wolf | Mectra Labs, Inc. | 2 |
| Anti-fog w/Pad | Xodus Medical, Inc. | 2 |
| Merocel® | Medtronic Xomed, Inc. | 2 |
| Cardinal Health | Cardinal Health 200, LLC | 2 |
| Anti-Fog w/ Pad; in Tray | Xodus Medical, Inc. | 2 |
| Key Surgical Mr. Clear Anti-Fog | Key Surgical, LLC | 1 |
Showing 12 of 41. All products under Anti Fog Solution And Accessories, Endoscopy
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K982465 | 1998-08-11 |
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.