Aspen® Anti-Fog Solution
2 catalogue numbers from DF-3100A, listed by Aspen Surgical Products, Inc., United States, under Anti Fog Solution And Accessories, Endoscopy. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
2catalogue numbers in this listing
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 | Aspen Surgical Products, 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, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K932449 |
| Record published | 2021-02-25 |
| Record revised | 2024-01-05 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Pack of 700 |
| Distribution end date | 2023-08-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DF-3100A | In distribution | |
| DF-3100A | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Mr. Clear Purple | Mectra Labs, Inc. | 8 |
| DeRoyal | Deroyal Industries, Inc. | 7 |
| 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 |
| 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
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.