Mr. Clear Purple
Mr. Clear Purple Needle Counter Box
5manufacturers in China registered for this device type
8catalogue 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 | Mectra Labs, Inc., United States |
|---|---|
| FDA product code | OCT |
| Device type | Anti Fog Solution And Accessories, Endoscopy |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Record published | 2019-01-28 |
| Record revised | 2020-01-13 (version 2) |
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 |
| Storage | Handling environment temperature 20 to 115 °F |
| Packaging | Inner pack of 20, case of 25, inner pack of 10 |
| Distribution end date | 2020-01-10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0600-AF011-000 | Withdrawn | |
| 0600-AF031-KR1-000 | Withdrawn | |
| 0600-AF031-GER-000 | Withdrawn | |
| 0600-AF131-000 | Withdrawn | |
| 0600-AF031-NF-000 | Withdrawn | |
| 0600-AF041-000 | Withdrawn | |
| 0600-AF031-000 | Withdrawn | |
| 0600-AF001-000 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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 |
|---|---|
| K993604 | 2000-03-03 |
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.